"A HOMEOPATHIC COMPLEX"

The present invention is directed to a homeopathic complex for use in the treatment of various diseases or disorders, particularly for use as an anti-infective agent and/or in the regeneration of diseased or damaged tissue.

Background

Homeopathy is a form of alternative medicine and traditional homeopathy has been practiced for nearly two hundred years all over the world. Homeopathic medicine has its underpinnings in what is referred to as the Law of Similars or the similia principle. The fundamental principle of homeopathy states that substances may be used to treat disorders whose manifestations are similar to those which they themselves produce in a healthy subject (Churchill Livingstone's International Dictionary of Homeopathy Edited by Jeremy Swayne (2000) page 193, 1st Edition).

Homeopathic tinctures differ to herbal tinctures in their method of production, base ingredients used and their dilution.

Homeopathic tinctures are derived from many materials, whereas herbal tinctures are derived from plant materials only. Homeopathic mother tinctures are made following monographs laid down in the HAB (GHP- German Homeopathic Pharmacopeia), EP European Pharmacopeia, French Homeopathic Pharmacopeia BHP British Homeopathic Pharmacopeia HPUS Homeopathic Pharmacopeia of the United States. While plants are the base ingredients for approximately 65% of homeopathic tinctures, the remainder ,are made from many mineral, animal or imponderable substances. Thus, the production of a homeopathic tincture involves the use of base ingredients from x-ray to diamond to Pulsatilla (the Wind flower).

A homeopathic mother tincture, comprising base ingredients such as for example fresh plants, is generally prepared by extracting the ingredients in a suitable solvent, followed by the steps of comminution, maceration and squeezing according to accepted homeopathic Pharmacopoeia. Suitable solvents include alcohol, water, water-alcohol mixtures, glycerine or isotonic sodium chloride solutions. Other

techniques include tituration (grinding) with lactose to form a powdered dilution. On the contrary herbal tinctures are prepared in a different manner generally involving the use of a solvent to extract the base ingredient without the maceration or grinding steps.

In homeopathy, a base preparation or mother tincture of a homeopathic remedy is made by liquid extraction (via maceration) of a herbal, mineral, animal or imponderable substance by dissolving the herbal, mineral, animal or imponderable in a solvent. In use, the mother tincture or 1x potency (1x10 ^'1 dilution) may be used as is, for example in diseases where the patient can benefit from the active principles within the tincture. This assumes that the base tincture is not of a toxic nature. Optionally, the mother tincture may be further diluted. Essentially, a series of dilutions are prepared from the base preparation or mother tincture. This step is called potentization and involves a series of dilutions. Between each series the diluted substance is succussed (shaken in a vigorous manner). The process of dilution and succussion leads to a gradual loss of chemical toxicity while gradually increasing the homeopathic potency. The more dilute remedies being of greater potency.

Thus, homeopathic tinctures require a further dilution step in the production of the mother homeopathic tincture. This means that a homeopathic mother tincture is a "Ix or 1 in 10 dilution of the base ingredient. Additionally, it is important to note that it is not possible to reconstitute a herbal mother tincture from a homeopathic mother tincture. Thus, what makes a tincture truly homeopathic is the additional dilution process to where the final mother tincture represents a dilution of 1 :10 of the base ingredient.

Thus, homeopathic tinctures differ to herbal remedies in that a further dilution is required in the production of homeopathic tinctures so that the base material is 10% of the final mother tincture. As expanded on above a homeopathic mother tincture from fresh plants is prepared by extracting the ingredients in a suitable solvent, such as a alcohol, water-alcohol mixtures, water, glycerine or isotonic sodium chloride solution are used as a vehicle (solvent) followed by the steps of comminution, maceration and squeezing. Other techniques include tituration (grinding) with lactose to form a powdered dilution. On the other hand, herbal remedies are less dilute than

homeopathic remedies and are prepared in a different manner merely involving the use of a solvent to extract the ingredient.

Homeopathic preparations as defined above must follow the monograph as laid down in the various homeopathic pharmacopoeias, for example the German Homeopathic Pharmacopeia (G.H.P. or H.A.B.), European Pharmacopeia (E.P.), French Homeopathic Pharmacopeia, British Homeopathic Pharmacopeia (B.H.P.) or the Homeopathic Pharmacopeia of the United States (H.P.U.S.).

The dilution and sucussion level of homeopathic drugs are denoted as "x", "X" or "d" for the decimal scale or centesimal "c", "C" scale or LM (Q) as 1 :50,000 dilutions. This is expanded in Table 1 below.

Table 1

For example, for a "3x" preparation, the mother tincture is diluted with nine parts of the desired diluent, in either liquid or powder form. The resultant mixture is then diluted a second time, in a ratio of one part mixture to ten parts solvent and the resulting mixture is diluted a third time in a ratio of one to ten. Therefore, the 3x or D3 potency is actually at 1x10 ³ (1/1000) of the mother tincture. Similarly, a 6x potency dilution would be at 1x10 ^" " of the original solution. In the "C scale" each dilution is

done with ninety-nine parts diluent to the original mixture. Therefore, a 3C potency dilution is at 1x10 ^'β potency of the original mixture. Ideally, x potency dilution is usually carried out with approximately 10 to 20 succussions, while C potency dilutions are carried out with anywhere from 10 to 100 succussions and in some cases 1000 sucussions between dilutions. The more stages of dilution and succussion a homeopathic solution has undergone, the higher the potency of that remedy.

These x and C scales are recognized by the main Homeopathic Pharmacopoeia such as the German Homeopathic Pharmacopoeia (G.H.P.), French Homeopathic Pharmacopoeia British Homeopathic Pharmacopoeia, the Homeopathic Pharmacopeia of the United States (H.P.U.S.) and the European Homeopathic Pharmacopeia.

When choosing the homeopathic remedy to administer, it is important to note that the homeopathic approach to treatment hypothesizes that the closer the matching of symptoms of the individual to be cured to those of the medicine being used, the greater the curing effect of the homeopathic treatment. This process is facilitated by these symptoms being catalogued in the homeopathic Materia Medica and various Homeopathic Repertories. The selection of the remedy is of prime importance in a successful homeopathic treatment. Of secondary importance, is the selection of the correct therapeutic potency. The potency of the medicine must be matched to the state of the patient and the state of the disease process. Thus, in a young healthy individual with an acute disease process a high potency medicine would generally be appropriate, whereas in an elderly patient with a chronic disease a low potency or even a diluted LM potency may be more appropriate.

In order to demonstrate the effectiveness of a homeopathic drug, the drug is tested by a "proving" in order to see how the drug will affect an otherwise healthy person. Hundreds of compounds have been tested in this manner and these are catalogued in the various Homeopathic Repertories and Materia Medica. Homeopathic repertories generally provide listings of the human anatomy (or in some clinical repertories clinical conditions are listed) and list associated symptoms and treatments for these symptoms. Materia Medicae list homeopathic drugs and identify the maladies and symptoms each drug treats. The material in the Materia Medicae is

derived from all the information about the homeopathic drug and includes data from homeopathic provings, toxicity, and clinical use. More over, where a repertory lists a symptom, it classifies possible treating compounds as either first, second or third degree and in some cases fourth degree remedies for that symptom. Typically, a homeopathic practitioner will prescribe homeopathic medicine that has the best overall recorded similarity to the overall disease picture in the patient. This also involves taking into account how important each symptom is in that picture especially the strange rare and peculiar symptom(s), mental, emotional, aetiological, general symptoms, local symptoms and modalities. A homeopathic medicine with first degree indications for a particular symptom picture is more likely to be used than a remedy with a similar second degree picture unless the second degree picture has a greater similarity to the overall patient picture. A homeopathic medicine with a third degree indication would be less likely to be used unless there was a greater similarity and particularly if there was a strange rare and peculiar symptom present. Homeopathic tinctures and their derivative potencies or dilutions can be used in the treatment of a wide variety of diseases, conditions and or symptoms.

Classical homeopathy involves the administration of a homeopathic medicine based on a single ingredient. The use of a homeopathic complex comprising multiple different ingredients is contrary to conventional classical homeopathy teachings and in some pharmacopoeia this is not recommended ("Hahnemann Revisited - A Textbook of Classical Homeopathy For the Professional" Luc DeSchepper, First Edition 2001 , "Achieving and Maintaining the Similimum Strategic Case Management for Successful Homeopathic Prescribing" LucDeSchepper, First Edition 2004, 'The Organon of the Medical Art" by Samuel Hahnemann edited by Wenda Brewster O'Reilly First Edition, 1996.)

The treatment of most conditions in humans or animals using conventional methodologies involves the administration of conventional drug treatments. Such conventional treatments can have major side-effects to the detriment of many internal organs. These side-effects, ranging from mild to severe, can prevent their application to many patients. For example, statins which are used in the treatment of high cholesterol have many side effects ranging from mild to severe. These include gastrointestinal symptoms. Statins can also have severe side effect on the liver and kidney. Rhabdomyolysis (the pathological breakdown of skeletal muscle) may lead to

acute renal failure when muscle breakdown products damage the kidney. Thus, with a condition like high cholesterol when it is being treated by statins, the patient must be continually monitored to assess whether unrelated systems are being adversely affected.

Many other therapies for a wide range of conditions also result in side effects ranging from mild to potentially lethal side effects. These side effects and other detrimental effects can also reduce patient compliance to the drug therapy. For example, many anti-arthritics and anti-inflammatories have side effects at the circulatory hepatic or nephrological level. Anti-anxiety drugs (anxiolytics) can have either a sedative side effect or other often more hidden behavioural effects can occur, such as dissociation or there may be a long term inability to cope without the drugs. It has been recorded that drugs used for the purposes of sedation have in some cases resulted in the aggravation of symptoms such as aggression following their use. For example, acepromazine/acetylpromazine (ACP) is used as a sedative/tranquilizer by veterinarians. ACP is frequently used in combination with other sedatives and anaesthetics to provide smoother sedation ACP can cause side effects, such as effects on blood pressure. In some cases the lower blood pressure remains long after the drug has been taken. Due to these side-effects, it may not be possible to administer ACP to some animals. Anti-pruritic drugs, which reduce pruritus, or itching, can have side effects such as drowsiness and lowering blood pressure.

Therefore, it is desirable to provide a treatment which addresses these issues and can mitigate at least some of the significant side-effects and problems associated with conventional therapies.

Furthermore, another problem with current conventional methodologies is that no therapy is 100% effective across a population no matter what condition is targeted. Any therapy which can improve effectiveness across a wider range of subjects would be desirable.

There is a need for less expensive, safer and more user friendly therapeutic agents for use in the treatment of a wide variety of conditions. Hence, the present invention is directed to specific homeopathic complexes which can treat a wide number of

disorders without the negative side effect and costs issues usually associated with conventional pharmaceuticals.

Statements of the Invention

According to a general aspect of the present invention, there is provided a homeopathic complex comprises a homeopathic tincture or dilutions thereof of a silica containing remedy, a mercury containing remedy, a snake or spider remedy, and a Calcarea or Sulphur salt or acid.

According to this general aspect of the invention, the homeopathic complex comprises a homeopathic tincture or dilutions thereof of Hepar sulphuris calcareum [Hep] or other similar profiled Calcarea or Sulphur salt or acids, Lachesis muta [Lach] or other remedy with a similar profile, Mercurius Solubilis [Merc] or Similar Mercury based remedy; and Silica [SiI] or other silica containing compounds.

According to a further general aspect of the present invention, there is provided a homeopathic complex as defined herein for use as an anti-infective agent and/or in the regeneration of disease or damaged tissue.

According to a further general aspect of the present invention, there is provided a method for the treatment or prophylaxis of infection and/or regeneration of disease or damaged tissue comprising administering to a subject in need thereof an effective amount of the homeopathic complex as defined herein.

Description of the Invention

In the specification the term "by weight" refers to the weight of the final composition and "by volume" refers to the volume of the final composition.

In this specification the term "homeopathic tincture and dilutions thereof includes a homeopathic mother tincture and/or its various dilutions or potencies derived from the homeopathic mother tincture. It will also be understood that the homeopathic tincture comprises one or more extracts derived from plant, mineral, animal and/or imponderable substances.

In the specification, it will be understood that the term "anti-infective" agent covers both "antimicrobial" or "antibacterial" effects and covers biocidal or biostatic activity against various types of organisms including, but not limited to, bacteria, fungi, viruses, yeasts and/or moulds.

Finally, in the specification, it will be understood that the homeopathic ingredients are referred to using different nomenclature or synonyms. For example, Hepar sulphuris calcareum can also be referred to as [Hep] or Hepar sulphuris, they all refer to the same homeopathic ingredient. Furthermore, for some ingredients, specific species names are given in places and family names are given in other places. For example, Echinacea is generally referred to in the description whereas in the examples the preferred Echinacea plants are mentioned, such as Echinacea angustifolia [Echi] and Echinacea purpurea [Echi-p]. These comments are applicable to most ingredients used in the homeopathic complexes of the invention. The different nomenclature and family/species for each ingredient is well known in the art and can be found in the homoeopathic literature. The following table highlights the different names, long names and short names given to the same homeopathic ingredient.

-

According to a first aspect of the invention, there is provided a homeopathic complex comprising a homeopathic tincture or dilutions thereof of

Hepar sulphuris calcareum [Hep] or other similar profiled Calcarea or Sulphur salt or acid;

Lachesis muta [Lach] or other remedy with a similar profile;

Mercurius Solubilis [Merc] or similar mercurius based remedy; and

Silica [SiI] or other silica containing compounds.

It will be understood that Hepar sulphuris calcareum [Hep], Lachesis muta [Lach], Mercurius Solubilis [Merc]; and Silica [SiI] may be replaced or supplemented with the

additional remdies as outlined below. The main characteristic of the additional remedies is that they have similar profiles to the remedy they replace or supplement.

Furthermore, it will also be understood that these remedies may be replaced or supplemented with chemical equivalents or bioequivalents of the homeopathic remedies which essentially mimic the active moiety within the homeopathic remedy and ideally results in an agent with a similar profile to the homeopathic remedy. For example, venoms such as snake or spider remedies may be replaced by ammonium carbonate. Additionally and by way of non-limiting examples, the active agent within the Solanacea family (e.g. Belladonna, Strammonium, Hyoscyamus) are the alkaloids, particularly the tropane alkaloids, and the active agent within the Loganiaceae family (e.g. Iganthia, Gelsemium, Nux Vomica) is strychnine (Strychnos). Other chemical equivalents or bioequivalents of homeopathic ingredients are well known in the field.

According to a specific embodiment, CaIc Sulph, CaIc SiI or similar profiled Calcarea or Sulphur or salts or acids thereof may be present in addition to or instead of Hepar Sulph.

It will be understood that other similar snake or spider remedies remedies with a similar septic shock profile to Lachesis muta can be used. Such remedies include but are not limited to Crotalidae (crotalus Horridalus), Tarentula Cubensis and/or Pyrogen.

Mercurius Solublis can also be known as Hydrargyrum, Mercurius vivus, Argentum vivum, Mercurius Solublis Hahnemanni, Metallic Mercury or Quicksilver. It will also be understood that Mercurius Solubilis may be replaced or complimented with many other mercury containing compounds. For example, Phytolacca decandra, also known as Vegetable Mercury, may be used. Phytolacca decandra has a high Mercury content and similar inimicable relationship to Mercury as discussed below.

Silica [SiI] can be known under any of its synonyms, such as Silica terra, Silicea terra, Flint, Silex, Silica anhydride, Quartz or Silicon dioxide or may be replaced or complimented with many other silica containing compounds such as Silica Marina Sea Sand.

_ _

This homeopathic complex comprising a homeopathic tincture or dilutions thereof of Hepar sulphuris calcareum or other similar profiled Calcarea or Sulphur salt or acid; Lachesis muta or other remedy with a similar profile, such as a spider or snake remedy, Mercurius Solubilis or other mercurius containing remedy with a similar profile (such as Phytolacca (vegetable mercury)) and Silica or other silica containing compounds with a similar profile other will be referred to as "Core A" within the specification and examples.

Essentially, Core A provides a general anti-infective homeopathic composition for use in the treatment of general infections and/or sepsis. Core A is essential to all the homeopathic complexes of the present invention. Essentially, Core A functions to allow the abortion, resorption, discharge or absorption of pus formation which develops in association with an infection and/or sepsis/septic infection.

Core A also provides for the re-growth and repair of damaged tissues.

This specific combination of the four homeopathic ingredients in Core A provides general anti-infective activity and is a combination which would not be recommended in most conventional homeopathic literature due to incompatibility of two of the ingredients. However, contrary to conventional teachings, we have found this specific combination is well tolerated and provides good general anti-infective activity.

Specifically, according to general homeopathic teachings Mercurius Solubilis and Silica are incompatible (Remedy Relationships by Thomas Blasig & Peter Vint 1 ^st Ed

2001 Published Hahnemann Institut) Silica Terra (SiI) and Mercurius Solubilis (Merc and SiI) should never be given immediately before or after each other. They are in homeopathic terms, "inimical" or incompatible (Nature's Materia Medica, January

2007 (3rd Edition) (Lotus Materia Medica (1 ^st & 2 ^rd Edition) Robin Murphy) and Concordant Materia Medica (First edition1994) Frans Vermeulen)). Based on classical homeopathic teachings, these ingredients interfere with the action of the other. However, we have surprisingly found that the homeopathic of the present invention uses both these homeopathic ingredients together without any detrimental effect.

Thus, unexpectedly and contrary to conventional homeopathic teachings, Core A advantageously provides for the dual functionality in terms anti-infective activity and re-growth and repair of damaged tissues of the homeopathic complex of the present invention. Thus, using this knowledge it was possible to combine mercury and silica in a way that was beneficial to the patient in need thereof. This has been used to advantage in a broad way in Core A.

Preferably, the homeopathic complex is provided in a potency range from mother tincture to approximately 100M (MM), preferably from mother tincture to 50M (CM) and including LM potencies.

Generally, a "low potency" according to the invention is in the "X" range and is ideally used for topical administration and the treatment of chronic conditions. It may also be used internally to treat the same infection state.

For such topical use "X" or decimal potencies are most appropriate due to their suitability for repeated use on a local area over a period of time, without inducing a homeopathic aggravation. When this homeopathic complex is made in such low potencies up to 18x/9c, preferably from mother tincture to approximately 9c, more preferably from mother tincture to approximatelyl 8x (18x and 9c are roughly equivalent in terms of dilution) it is ideal for topical use, for example as a topical anti- infective cream, gel or liquid healing composition. This comment is applicable to all cores (i.e. Core A and the following Cores) and all combinations of cores. There are some exceptions to this rule for example. It will be understood that some homeopathic ingredients may be administered as a mother tincture, however, due to Regulatory constraints in some countries, some homeopathic ingredients may not be administered as a mother tincture and must be diluted to 2x, preferably 6x or 8x or higher for administration. A few non-limiting examples include Aesculus hippocastanum, Arsenicum Album, Cantharis, Gelsemium, Mezereum, Nux Vomica, Phosphorus Staphysagria, Nosodes from the additional Cores C to D would not generally be recommended for used a Mother Tincture because of Regulatory constraints in terms of safety below certain potencies. This is explained in more detail in the various pharmacopeia, for example, the German or American Homeopathic Pharmacopeia.

When this formulation is made in "high potencies" according to the invention, in the C potency range, preferably 30c plus, more preferably 200c plus, it is ideal for internal use, for example as a liquid for oral or internal administration. Thus, at these potencies, the homeopathic complex works as an internal anti-infective healing composition. Again, this comment is applicable to all cores (i.e. Core A and the following Cores) and all combinations of cores. In some situations, there are exceptions to this rule for example, Arsenicum lod, Hydrastis, Laurocreasus and Gun Powder (which may be used in addition to Core A) can also be used in the low potency range even when formulated for internal administration, as they and other homeopathic ingredients demonstrate significant effects in low potency.

Preferably, "high potency" according to the invention is from about 30c to about 1 M.

"Very high potency" according to the invention is generally from about 1M to 10M ₁ and includes LM potencies.

In the "high" to "very high potency" (C or M potency dilution), the homeopathic works as an acute anti-infective healing composition in situations needed a fast-acting response, for example an anti-infective healing first aid remedy. Thus, when used internally, it will be understood that a high potency in the C range to 1 M is generally used for the treatment of acute conditions. The high to very high potencies work best in acute conditions particularly as a complex for first aid treatment from such minor injuries as cuts and grazes to such major events as strokes or traumatic injuries. However, it will also be understood that the general anti-infective composition or mastitis treatment composition of the invention can also be used in high potencies for the internal treatment of infections and/or mastitis.

When the homeopathic composition of the invention is given internally at low potencies, generally speaking Core A causes an abscess to rupture and at high potencies, generally speaking Core A causes an abscess to be absorbed. We have also found that at potencies from approximately 9c to around 30c, so called "medium" potencies (between the low and high potencies), that the homeopathic complex can cause both promote or prevent absorption of the abscess or promote or prevent rupturing.

_ _

Thus, the potency of the homeopathic ingredients will generally determine whether it can be applied topically or internally to achieve the best results. This unexpected "biphasic" effect of the composition at different potencies, was observed by the inventors in animals, particularly canines, when the homeopathic composition was administered. At different potencies the homeopathic ingredients work in different ways and should be administered in different ways.

The homeopathic complex according to the present invention can be used as an anti- infective agent in the prophylaxis or treatment of microbial infections.

When used as an anti-infective agent, the homeopathic complex can treat most general microbial infections or sepsis. Advantageously, it has been found that the homeopathic complex according to the present invention can be used in the treatment of Methicillin-resistant Staphlococcus aureus (MRSA) or other associated conditions, including other antibiotic resistant bacteria or pathogens. In this manner, the homeopathic complex of the invention can provide the effect of a conventional antibiotic without the many side effects associated with such conventional treatments.

Some non-limiting examples of microbial infections include external microbial infections of the skin, eyes (including conjunctivitis), nails, hoof, ears (including otitis) Some non-limiting examples of microbial infections include internal microbial infections such as mastitis, pneumonia, metritis, joint infections; abscesses acute, chronic, resorptive stage; infected, inflamed or swollen glands.

Additionally, it has been found that the homeopathic complex according to the invention also promotes the regeneration of diseased and/or damaged tissue which includes the re-growth and repair of damaged tissues and/or cells. When used to promote the regeneration of diseased and/or damaged tissue the homeopathic complex can treat multiple conditions. Firstly, the homeopathic complex can treat a multitude of skin conditions including but not limited to general infection, inflammation, pyrexia, wound healing, skin restoration and repair. It can also treat a very wide range of skin disorders such as eczema, purities, sun damage, wrinkles, cracked skin, warts, burns such as sun, heat radiation and chemical burns, piles in humans. Thus, the homeopathic complex can speed the repair/healing of diseased.

- o -

damaged, wound or incised tissue deriving from wounds, cuts, cracks, grazes, bites, ulcers. Such damaged tissue may be septic, indolent (non-healing), decubitus (bedsores and pressure damaged skin), recurrent or reopening. Furthermore, the homeopathic complex may be used in the treatment of burns including heat, radiation including sun, x-ray treatment and prevention, chemical and/or friction/work blisters. Additionally, the homeopathic complex may be used in tissue regeneration in, for example, grafting such as skin grafting or fracture repair.

The homeopathic complex according to the present invention has many advantageous properties including safety, speed of action, ease of use and efficacy. These advantages are outlined in the Example section below.

The homeopathic complex lacks toxicity and associated side effects. It is well tolerated and is compatible with many conventional pharmaceuticals. It provides for a rapid response time and is highly effective. It can be delivered in multiple formats from topical to oral to parenteral and there are minimal treatment requirements which increase patient compliance and enhancing successful outcomes. Furthermore, it provides for a consistent response and action across all species and across a wide range of conditions or even types of the same condition

It will be understood that Core A provides the general anti-infective and/or repair/re- growth activity. However, Core A may be supplemented by the addition of further homeopathic complexes. There are three other general core groups of homeopathic complexes which may be added to Core A to provide for additionally functionality and to improve efficacy. These are homeopathic complexes which will be known as Core B, Core C and Core D throughout the specification and examples. The addition of Cores B to D can increase efficacy and be used to tailor the homeopathic complex to the specific application needed.

Core B ingredients are involved in the promotion of tissue healing.

Ideally Core B comprises a homeopathic tincture or dilutions thereof derived from the following ingredients:

the Ranunculacea family, preferably the Aconite Family or Aconitine, more preferably Aconite napellus [Aeon] ; the Compositae family, preferably Arnica montana [Arn] ; Bellis perennis [BeII- p]; Calendula Offcinalis [Calen]; Chamomilla Matricaria [Cham]; Millefolium achillea [Mill]; Carduus Marianus; and/or Echinacea, preferably Echinacea angustifolia [Echi]; Echinacea purpurea [Echi-p] ; the Solanacea family, preferably Belladonna [Bell] ;

Arsenicum, preferably Arsenicum iodatum [Ars-i] and/or Arsenicum Album;

Bryonia alba [Bry] ; Hamamelis virginiana [Ham] ;

Hypericum Perforatum [Hyper];

Ledum palustre [Led] ;

Phytolacca decandra [Phyt] ;

The Anacardiacae family preferably Rhus Toxicodendron [Rhus-T.]; The Rutaceae family preferably Ruta Graveolans [Ruta];

Stellaria media [Stel]; and/or

Symphytum officinale [Symph].

According to a preferred embodiment, Core B comprises a homeopathic tincture or dilutions thereof of the following:

Aconite napellus ;

Arnica montana ;

Arsenicum iodatum; Belladonna ;

Bellis perennis ;

Bryonia alba ;

Calendula Officinalis ;

Echinacea angustifolia ; Echinacea purpurea ;

Hamamelis virginiana ;

Hypericum Perforatum ;

Ledum palustre ;

Millefolium achillea ; Phytolacca decandra ;

_ _

Rhus Toxicodendron ; Ruta Graveolans ; and/or Symphytum officinale.

The combination of the ingredients in Core A and Core B provides a general anti- infective homeopathic composition for use in the treatment of general infections/sepsis.

Optional ingredients which may be included in Core B are Thuja Occidentalis [Thuj], Chamomilla Matricaria[Cham], Stellaria media [Stel] and/or the Sulphurs, preferably Sulphur[Sulph]. A further optional ingredient for Core B is Graphites naturalis [Graph].

Additional ingredients which may be added to Core B are Urtica urens [Urt-u] (equivalent to Urtica dioica), Apis mellifica [Apis], Umbelliferae preferably Conium maculatum [Con] and/or Gunpowder [Gunp].

Core C ingredients function as constitutional modifiers and work for certain types of individuals boosting their response to treatment. For example, CaIc Carb boosts the health of large boned heavy often flabby individuals while Phosphorus helps lean thin high energy outgoing individuals. This is particularly important when tailoring the treatment to the treatment of groups e.g. mastitis in a dairy herd will tend toward the lean side while a beef herd would tend toward the heavy side. The skilled homeopathic practitioner would be able to determine the appropriate remedies to administer from the following groups.

Core C comprises constitutional modifiers preferably selected from the following homeopathic tincture or dilutions thereof of:

The Arsenicums, preferably Arsenicum album [Ars];

The Barytas and Cabonicums, preferably Baryta carbonica [Bar-c] and/or Kali Carbonicum ;

Carbo vegetabilis [Carb-v];

The Calcareas, preferably Calcarea carbonica [CaIc]; Calcarea fluorica [Ca!c-f] and/or Calcarea phosphorica [Ca!c-pJ;

Gelsemium sempervirens [GeIs]; lodium purum [lod];

The Kalis, preferably Kali iodatum [Kali-i] and/or Kali Carbonicum

Lacs, preferably Lac caninum [Lac-c]; Lac vaccinum defloratum (skimmed) and/or Lac Vaccinum (cow);

Lycopodium clavatum[Lyc];

The Natrums and Muriatricums, preferably Natrum Mur

Nux vomica [Nux-v];

Phosphorus, preferably Phosphorus [Phos] and/or Ferrum Phos; the Ranunculacea family, preferably Pulsatilla nigricans [PuIs] and/or

Staphysagria [Staph];

Sabal serrulata [Sabal];

Sepia succus [Sep];and/or

Zincums preferably Zincum metallicum [Zinc].

Core C may also comprise remedies for severe septic infection selected from a homeopathic tincture or dilutions thereof of Baptisia tinctoria [Bapt] and/or Pyrogen [Pyrog].

Core C may also comprise remedies for blood in milk selected from a homeopathic tincture or dilutions thereof of Bufo rana [Bufo] and/or Ipecacuanha [Ip].

Core C may also comprise a homeopathic tincture or dilutions thereof of Astragalus membranaceus [Astra-mem].

Core D functions as anti-puritic/anti-inflammatory ingredients. When used in combination with any of the other Cores, this care provides additional anti-puritic/anti- inflammatory functionality of the homeopathic core. Core D comprises a homeopathic tincture or dilutions thereof of the following ingredients:

Adrenalin [Adren] ;

Aesculus hippocastanum [Aesc] ;

Alfalfa;

Aurums ; The Antimoniums, preferably Antimonium Tart

_ -

Berberis Vulgaris ;

Cactus Grandiflora ;

Caladium seguinum [Caladj;

Cantharis vesicatoria[Canth]; Carduus Marianus ;

Cocculus indicus [Cocc];

Chelidonium;

China officinalis ;

Chionanthus virginica ; Drosera rotundifolia ;

Equisetum hyemale ;

Euphrasia:

Galium Aprine ;

Grindelia (the Compositae family); Histaminium (Histamine) [Hist];

Hydrastis canadensis [Hydr] ;

Lappa Articum (the Compositae family);

Lavender [Lav-v.] ;

Lobelia inflata ; Mezereum [Mez];

Nitric acid [Nit-ac];

Paeonia Officinalis[Paeon];

Prednisolone [Predni.];

Ranunculus bulbosus [Ran-b]; Rumex crispus [Rumx] ;

Solidago virgaurea ;

Strophantus hispidus (the Compositae family) ;

Taraxacum officinale (the Compositae family) ;

Triticum Repens ; The Stannums preferably Stannum Met ; Thiosinaminum [Thiosin]; Uva Ursi ; Veratrum Album; Cuprum Met; and/or Sol [SoI].

Advantageously, Cores D when administered with any or all of Cores A to C can be used as an anti-itch treatment, pile treatment, stroke treatment, wart treatment, scar treatment, anti-wrinkle treatment. Core D may act as an anti-pyretic, anti- inflammatory and/or analgesic. For example, Thiosinaminum [Thiosin] is used to treat scarring (similar to silica and graphites) and Sol [Sol] is used to treat sunburn. Many forms of application may be contemplated. In addition, as with other embodiments of the invention, the potency can be altered depending on the end use.

Furthermore, the homeopathic complex of the present invention, as defined in cores A to D above, may also comprise nosodes. Nosodes are homeopathic remedies that are made from the specific products of a particular disease. This can be tissue containing the actual disease agents or tissue affected by those agents. Sometimes nosodes are made from vaccines containing the organisms. The nosodes are prepared in a diluted and potentized form just like all other homeopathic medicine. There is no potential for an animal to become infected with a given disease agent from a nosode because of the pharmaceutical process that occurs which dilutes and inactivates any viable organisms, particularly when manufactured using the Hahnemannian method and they are used at 30c and above. Nosodes are ideally selected from Tuberculinum bovinum, Tuberculinium aviaire, Staphylococcus aureus, Strepococcus, Corynebacterium, E. CoIi, Colibacillinum, Bacillinum and/or Medorrhinum.

As expanded on above in relation to Core A ₁ an important aspect of the present invention is the potency of the homeopathic complex. Specifically, the homeopathic complex may be provided at different potency levels in order to work in different areas and on different conditions. Thus, changing the potency, by dilution and succession, will give a homeopathic complex with a different mode of action. Thus, a significant advantage of the present invention is that both the homeopathic ingredients of Cores A to D can be combined in different ways and the potency can be altered. Different combinations of Cores and different potencies will result in a homeopathic complex used for different conditions.

The invention will now be described in relation to specific embodiments of the invention and their end uses.

_ _

According to a one specific embodiment of the invention, there is provided a general anti-infective homeopathic composition comprising a homeopathic tincture or dilutions thereof of:

Hepar Sulph, Lachesis, Merc, SiI; and

Aconite napellus ; Arnica montana ; Arsenicum iodatum; Belladonna ; Bellis perennis ; Bryonia alba ; Calenula Offcinalis ; Chamomilla Matricaria ; Echinacea angustifolia ; Echinacea purpurea ; Graphites naturalis ;

Hamamelis virginiana ; Hypericum Perforatum ; Ledum palustre ; Millefolium achillea ; Phytolacca decandra ; Rhus Toxicodendron ; Ruta Graveolans ; Stellaria media ; Sulphur ; Symphytum officinale; and Thuja Occidentalis.

Thus, the general anti-infective healing composition comprises a homeopathic tincture or dilutions thereof of Core A, Core B, Graphites, Sulphur, Thuja, Chamomilla and Stellaria.

Optional ingredients which may be included are Conium maculatum and/or Gunpowder (depending on Regulatory constraints).

Each ingredient is ideally present from 0.1 to 20% v/v based on the volume of the total composition. Ideally, each ingredient is present in equal ratios/proportions.

Ideally, the potency of each ingredient is in the low potency range from mother tincture to approximately 18x/9c, preferably 12x/6c. This potency is ideal for topical administration, in the form of for example, a topical cream, gel or liquid. Optionally, this homeopathic composition may be given in a high potency and used internally as a general anti-infective healing composition. We have found the best effects are when the composition is admistered in low potency for administration.

According to a preferred embodiment, this homeopathic composition is formulated as a topical cream. A non-active base is ideally used, comprising lanolin, petroleum and mineral oil. Such as base could comprise, for example, approximately 15 to 35%, preferably 25% lanolin, approximately 40 to 60%, preferably 50% petroleum with 15

- -

to 25%, preferably 25% mineral oil and would be ideal for use in cold climates. It will be appreciated that any other non-active bases known may be used.

The following table outlines suitable potency ranges for each of the ingredients when used in a topical general anti-infective healing formulation.

It will also be understood that some homeopathic ingredients may be administered as a mother tincture, however, as explained before, for Regulatory reasons in some countries some homeopathic ingredients may not be administered as a mother tincture and must be diluted to 2x, preferably 6x or 8x or higher for administration. These are indicated on the table below.

- -

^* these potencies are ideal for use in the USA. Some minor adjustments to the potencies are needed for Europe where for Regulatory reasons 3x potencies are not allowable and must be 4x or higher. Again, this will largely be determined in the country of interest based on Regulatory constraints.

^** As stated above, Sulphur for example is not soluble below 4x but can be mixed into a cream as sulphur powder that has been titurated with lactose to form a titurate. Arsenicum lod, Sulphur, Silica, Graphite and Hepar SuIp are also insoluble and form titurates not tinctures. Lachesis is best prepared initially in glycerine (to preserve the protein activity of the venom) as it can be denatured by both alcohol and lactose.

According to this embodiment of the invention, to make an anti- infective cream, each ingredient is made according to the potency range above and this is done by different methods depending on whether it is a tincture or titurate. A titurate refers to the insoluble homeopathic ingredients, such as Arsenicum lod, Sulphur, Silica, Graphite, Hepar SuIp, Lachesis etc, which are diluted and potentised by grinding with lactose. A tincture is as defined previously and is diluted and potentised in the usual manner by sucussion in an alcohol and water premix. The tincture and titurates are then combined with each other and the base cream. These comments about tincture and titurates are relevant to all embodiments/compositions of the invention.

Each ingredient is ideally combined in equal proportions in a non-active cream base. Ideally, the combined ingredients are combined with the cream from approximately 1 to 10% w/v based on the total weight of the final homeopathic composition. Preferably, the combined ingredients are combined with a cream at from 3 to 6% w/v based on the total weight of the final homeopathic composition.

According to a more specific embodiment of the invention, there is provided a general anti-infective homeopathic composition which can be used in the treatment of mastitis.

Mastitis is initially caused by microbial infection through damaged skin. In particular, mastitis has a tremendous economic importance for the dairy industry as the present antibiotic therapies reduce usable milk yield. Thus, alternative therapies to conventional antibiotic therapies are under evaluation. Common causal microorganisms found in" mastitis include:

- Staphylococcus aureus ;

- Staphylococcus albus ;

- Streptococcus species e.g. agalactia, uberis, dysgalactia ;

- Escherichia coli ; - Salmonella species ;

- Mycobacterium tuberculosis ; and/or

- Fungal mastitis e.g. Candida albicans and Cryptococcus neoformans.

Such a mastitis treatment ideally comprises a homeopathic tincture or dilutions thereof of:

Hepar Sulphuris Calcareum, Lachesis, Merc Sol, Silicea; and

Aconitum Napellus, Arnica Montana, Arsenicum lod, Belladonna, BeIMs

Perenis, Bryonia AIb, Calenula Offcinalis, Chamomilla Matricaria, Conium maculatum, Echinacia augustifolia, Echinacia Purpurea, Graphites, Hamamellis Virginia, Hypericum Perforatum, Ledum, Millefolium, Phytolacca decandra, Ruta Graveolans, Rhus Toxicodendron, Stellaria Media, Sulphur, Symphytum, Urtica Urens and Thuja Occidentalis.

Essentially, this mastitis treatment comprises Core A and Core B plus Chamomilla Matricaria, Stellaria Media, Graphites, Sulphur and Thuja, Conium and Urtica.

- -

Gunpowder is an optional homeopathic ingredient for this homeopathic composition and its use depends on Regulatory constraints in the applicable country.

The homeopathic complex of the present invention may be use to treat elevated Somatic Cell Counts, to prevent Mastitis and in the treatment of mammary hypertrophy and other hypertrophic conditions.

Again, each ingredient is ideally present from 0.1 to 20% v/v based on the volume of the total composition. Ideally, each ingredient is present in equal ratios/proportions.

Ideally, the potency of each ingredient is in the low potency range from mother tincture to approximately 18x/9c, preferably 12x/6c. This potency is ideal for topical administration, in the form of for example, a topical cream, gel or liquid. Optionally, this homeopathic composition may be given in a high potency and used internally as a mastitis treatment composition. We have found the best effects are when the composition is administered in low potency for administration.

According to a preferred embodiment, this homeopathic composition is formulated as a topical cream. A non-active base is ideally used, comprising lanolin, petroleum and mineral oil. Such as base could comprise, for example, approximately 15 to 35%, preferably 25% lanolin, approximately 40 to 60%, preferably 50% petroleum with 15 to 25%, preferably 25% mineral oil and would be ideal for use in cold climates. It will be appreciated that any other non-active bases known may be used.

The following table outlines suitable potency ranges for each of the ingredients when used in a topical formulation for mastitis treatment.

^* these potencies are ideal for use in the USA. Some minor adjustments to the potencies are needed for Europe where for Regulatory reasons 3x potencies must be 4x or higher. Again, this will largely be determined in the country of interest based on Regulatory constraints.

^** As stated above, Sulphur for example is not soluble below 4x but can be mixed into a cream as sulphur powder that has been titurated with lactose to form a titurate. Arsenicum lod, Sulphur, Silica, Graphite and Hepar SuIp are also insoluble and form titurates not tinctures. Lachesis is best prepared initially in glycerine (to preserve the protein activity of the venom) as it can be denatured by both alcohol and lactose.

Optionally, nosodes from Tuberculinum bovinum, Tuberculinium aviaire, Staphylococcus aureus, Strepococcus, Streptococcus uberis Corynebacterium, E.

- -

CoIi, Colibacillinum, Bacillinum and/or Medorrhinum may be used. Ideally, such nosodes are present in a potency range from 6x to 1 M, preferably from approximately 6x-12x/6c. It will be understood that any nosode of any pathogen or pathological material including those involved in the condition to be treated may be used.

A further anti-infective mastitis treatment comprising Core A; Core B plus Stellaria media, Chamomilla matriaca, Sulphur and conium; and Core C without Arsenicum album, Gelsemium, Lac vaccinum and Staphlysagria. Ferrum Phos, Natrum Mur, Kali Carbonicum. This mastitis treatment was used in Example 10.

- -

- -

- -

The composition as defined above is ideal for internal use and is in the C potency range.

Ideally, this homeopathic composition is in a form suitable for internal use, for example a liquid with excipients being alcohol and water.

Optionally, nosodes are combined with this homeopathic mastitis treatment composition. Suitable nosodes are outlined in the following table.

- -

Ideally, the nosodes are added in equal proportions/ratios.

According to another embodiment of this aspect of the invention, an effective mastitis treatment comprises the use of the homeopathic composition defined above for internal use administered concurrently with the previously defined topical mastitis treatment.

According to a more specific embodiment of the invention, there is provided a general anti-infective homeopathic composition used in the treatment of trauma or shock comprising a homeopathic tincture or dilutions thereof of the following ingredients:

Hepar Sulphuris Calcareum, Lachesis, Merc Sol, Silicea; and

Aconite; Arsencium lod ; Arnica Montana ; Apis ;

Belladonna ; Bellis Perennis ; Bryonia ; Calendula ; Cantharis ; Carbo Veg ; Crategus ;

Echinacea Augustifolia ; Echinacea Purpura ; Ferrum Phos ; Gelsemium ;

- -

Hammamellis ; Hypericum ; Laurocerasus ; Ledum ; Millefolium ; Nux Vomica; Phytolacca ; Rhus Tox ; Ruta Grav ; Symphytum ; and Staphysagria.

Essentially, this homeopathic composition comprises Core A; Core B with Chamomilla matricaria and Stellaria media, Sulphur, Apis and Urtica; Core C ingredients Carbo veg, Gelsemium, Nux Vomica and Phos; and Cantharis.Laurocerasus, Crategus and Ferrum phos.

The following table outlines suitable potency ranges for each of the ingredients.

- -

Ideally, this homeopathic composition is in a form suitable for internal use, for example a liquid with excipients being alcohol and water.

The homeopathic ingredients are combined from approximately 0.1 to 20% v/v based on the total volume of the final homeopathic composition. Each ingredient is ideally combined in approximate equal proportions (1 :1 ratio) in the liquid excipient.

It will be understood that the homeopathic complexes of the present invention may be used in the both human medical and veterinary applications and are trans-species in action. Indeed, as shown in the Examples, the homeopathic complexes work in a wide variety of species, from companion animal (e.g. canines, felines to exotic parrot etc) to farm animals (e.g. equines and bovines etc) and to humans to name a few.

_ _

It will be understood that the general mode of action common to all the homeopathic complexes of the present invention, is the treatment of microbial infections and/or the repair and re-growth of damaged cells or tissue.

Specific applications of the homeopathic composition according to the invention, include but are not limited to treatment of the following conditions:

Wound treatment;

Fracture treatment; Dermatitis, including photo-dermatitis;

Sun burn;

MRSA Infection;

Mastitis;

Stroke; Pneumonia;

Hepatitis;

Nephritis; and/or

Detoxification.

Some specific non-limiting uses of the homeopathic complex are outlined as follows.

The homeopathic complex may be used in the treatment of various skin conditions including eczema and the like. Advantageously, we have found that scars are either prevented or minimized. Thus, the homeopathic complex may be used as a scar treatment.

The homeopathic complex may also be used in the treatment of mastitis, both acute and chronic. Mastitis is a widespread condition in many animals, in particular cattle. Conventional treatments for mastitis involve the use of antibiotics which is not desirable for commercial milk production. Any treatment which results in the reduction of the use of antibiotics would be advantageous for commercial milk production in cows. Thus, the generation of a new therapy for the treatment of mastitis which does not involve is desirable.

_ _

The homeopathic complex may also be used for detoxification and such a composition would generally comprise Core A and some of Cores B, C and D.

According to another aspect of the present invention, the homeopathic complex can be used as a cosmetic skin preparation. For example it may be used as an anti- wrinkle cream in the repair and or regeneration of skin cells.

Ideally, the homeopathic complex is manufactured according to a competent homeopathic pharmacopeia such as the German, US, UK, EU and/or French Homeopathic Pharmacopeias. Preferably, the homeopathic complexes are provided in a potency range from 1X to 12X, more preferably from 3X to 12X for the purposes of analytical traceability (Churchill Livingstone's International Dictionary of Homeopathy Edited by Jeremy Swayne (2000) page 193, 1 st Edition). Although, it will be understood that any potency from homeopathic tincture upwards can be used provided that the dangers of toxicity with very low potencies or tinctures are managed and all Official Regulatory conditions are met.

Homeopathic complexes are generally prepared in liquid carrier solutions (as a tincture) but may also be extracted in, for example, lactose by trituration and may thereafter be prepared in various delivery forms. For example, the extracted material of the homeopathic ingredient may be extracted in liquid form, using an alcohol and water solvent. This is then followed by comminution, percolation, maceration and squeezing techniques. When extracted in liquid form the resulting solution can contain anywhere from one part drug to three parts mother tincture although this strength can vary from 10 to 50% depending on the monograph used. What makes a tincture truly homeopathic is the additional dilution process to where the final tincture represents a dilution of 1 :10 of the drug in effect a 1x dilution. Titurates of insoluble homeopathic ingredients may also be made. Extraction of the homeopathic ingredient by tituration may take place using lactose to result in a solid or powder extract done up to 3c or third centesimal dilution. The homeopathic tincture or titurate may then be combined with a base for use as a topical preparation or be used directly as a liquid oral preparation. Alternatively, it may be sprayed or impregnated onto various solid mediums, such as a tablet.

_ _

All the complexes according to the present invention may be used for topical including eye drops, oral, transdermal, implanted, suppository, or parenteral administration in a wide variety of forms such as gels, spray, liquids, powders, tablets, pillules, lotions, liniments, ointments to give just some examples. It will be understood that the homeopathic complex is made in the usually homeopathic manner according to homeopathic guidelines. It may then be administered as it is, or as a homeopathic dilution thereof. It may be administered in different ways by combining the complex with a delivery means, such as a cream or spray for topical use or a tablet for oral administration etc.

According to one specific embodiment of this aspect of the invention the homeopathic complex is in the form of an oral preparation, such as a dry dose form including a powder or tablet. Preferably, the homeopathic complex is provided in the form of a dosage unit form selected from a group consisting of tablets, capsules, pellets, gel caps, pills, pillules, globules, granules, crystals and suppositories. For example, tablets comprising lactose and sucrose may be used.

Alternatively, the homeopathic complex according to this aspect of the invention may be in the form of a liquid preparation, such as a syrup or paste, spray or drops. Delivery of the liquid preparations may be in the form of injections, eyedrops, eardrops, nasal sprays, inhalers or diffusers.

According to another embodiment of this aspect of the invention the homeopathic complex may be in the form of a topical preparation such as an ointment, cream, lotion, oil, liniment, liquid and gel, such as a hydrophilic ointment.

Daily to twice or thrice administration of the homeopathic complex for a period of days is contemplated. It may be applied topically as needed, orally for daily dosage in unit dosage form or in liquid drops.

Conventional pharmaceutical excipients or cosmetic excipients suitable for the deliver system used can have the homeopathic complex incorporated into them or the homeopathic complex can be applied to the end product or packaged with the end product.

_ _

Pharmaceutical excipients are substances other than the pharmacologically active drug or prodrug which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form. They are classified by the functions they perform in a pharmaceutical dosage form. Principal excipient classifications or functions include, but are not limited to the following:

Binders;

Disintegrants;

Fillers (diluents); Lubricants;

Glidants (flow enhancers);

Compression aids;

Colors;

Sweeteners; Preservatives;

Suspensing/dispersing agents;

Film formers/coatings; and/or

Flavors.

Some, for example, comprise the product's delivery system. These transport the active drug to the site in the body where the drug is intended to exert its action. Others will keep the drug from being released too early in the assimilation process in places where it could damage tender tissue and create gastric irritation or stomach upset. Others help the drug to disintegrate into particles small enough to reach the blood stream more quickly and still others protect the product's stability so it will be at maximum effectiveness at time of use. In addition, some excipients are used to aid the identification of a drug product. Last, but not least, some excipients are used simply to make the product taste and look better. This improves patient compliance, especially in children. Although technically "inactive" from a therapeutic sense, pharmaceutical excipients are critical and essential components of a modern drug product. In many products, excipients make up the bulk of the total dosage form.

Ideally this formulation is provided in a form suitable for topical administration. As such, it may be delivered as a topical cream, lotion, gel, ointment, liniment, eyedrops,

spray, skin patch/dressing or combined with a conventional topical medication or skin treatment.

For topical administration, the homeopathic formulation can be combined into any commercially available base. For examples, the base may comprise approximately

Lanolin from approximately 15 to 35%, preferably 25% Mineral oil from approximately 15 to 35%, preferably 25% Petroleum from approximately 40 to 60%, preferably 50% at 2oz/lb.

Alternatively the base may be a silcox base or a non-lanolin non-mineral oil aqueous cream.

In addition, the homeopathic complex may be administered as a combination therapy, for example, at the same time as a conventional pharmaceutical, e.g. antibiotic, nutritional supplement or food.

In this specification the term "pharmaceutical" or "pharmaceutical composition" covers any chemical or biological substance, synthetic or non-synthetic which when taken by a subject will alter the function of that subject. Such substances ideally are intended for use in the treatment or prevention of disease in man or other animals. As such this term encompass more that conventional drugs or medicines and can also cover food, medicines, vitamins and minerals in general. Furthermore, the term "pharmaceutical" also the substance however it is made and, as such, encompasses biopharmaceuticals, biotechnology-derived treatments (including gene therapy) and phytotherapies.

In this specification the term "combination therapy" is used broadly to cover the simultaneous administration of the homeopathic complex and the pharmaceutical composition. As such, the homeopathic tincture may be packaged separately to the pharmaceutical composition which is provided with a set of instructions for coadministration. The term "combination therapy" also covers the combination of the homeopathic complex with the pharmaceutical composition as a single entity. In this way, the homeopathic complex may be combined or integrated with the pharmaceutical composition during or after manufacture. For example, the

homeopathic complex when in liquid form may be sprayed onto the pharmaceutical composition. Alternatively, the homeopathic complex may be provided in liquid or powder form and may simply be combined or mixed with the pharmaceutical composition during manufacture. In this manner, the pharmaceutical composition acts as a delivery system for the homeopathic composition.

The co-administration of a conventional drug and a homeopathic according to the invention goes against Classical Homeopathic teachings and techniques. According to Classical/conventional homeopathic teachings, homeopathic complexes must be taken on their own at least 20 minutes after ingesting any food or drink. On the contrary the present invention dictates that the homeopathic complex is either part of a combination therapy or co-administered with a pharmaceutical composition. This would not be expected in the field of classical homeopathy.

According to another aspect of the invention, there is provided a homeopathic complex of the invention for use in therapy.

Ideally, the homeopathic complex of the invention is for use in the treatment or prophylaxis of infection as an anti-infective agent. Specifically, the homeopathic complex of the invention may be used in the treatment of mastitis. Specifically, the homeopathic complex may be used in the treatment or prophylaxis of MRSA and other type of multi-resistant infections. Additionally, the homeopathic complex of the invention may be used in the regeneration of diseased or damaged tissue. In addition, the homeopathic complex of the invention may be used in the treatment of skin conditions, including acne, general infection, inflammation, pyrexia, wound healing, skin restoration and repair and skin disorders including eczema, puritis, sun damage, wrinkles, cracked skin warts, burns such as sun, heat and radiation burns and/or piles. The homeopathic complex of the invention may be used in the treatment of a stroke or as a first aid remedy.

According to another aspect of the invention, there is provided a method for the manufacture of a medicament comprising the homeopathic complex of the invention for use in the treatment or prophylaxis of infection and/or the regeneration of diseased or damaged tissue.

According to yet another aspect of the present invention there is provided a method for the treatment or prophylaxis of infection and/or the regeneration of diseased or damaged tissue in a subject comprising the steps of administering an effective amount of a homeopathic complex of the invention claimed to a patient in need of such treatment.

The invention will now be described by reference to the following non-limiting figures and examples.

The invention will now be described by reference to the following non-limiting figures and examples.

Figs. 1a & 1b show the Feline of Example 2 pre-treatment and 24 hours later;

Figs. 2a & 2b show the "Sambo" Equine Gelding at Day 1/Day 11 of Example 3a prior to treatment (Fig. 2a) and after treatment (Fig. 2b);

Figs. 3a & 3b show the pig of Example 3b prior to treatment (Fig. 3a) and after treatment (Fig. 3b);

Fig 4 show the Cavalier King Charles Female of Example 4 within 24 hours start of treatment;

Fig. 5 shows the Canine Collie of Example 5;

Figs. 6a - 6d show the Bichon Frise Male 6 years of Example 6. The state of the wound is and the repairs due to the cream are shown in Figure 6a to 6d. Fig 6b shows the change at day 12. Fig 6c shows the change within 30 days and Fig 6d shows that within a year the scar was virtually completely gone and almost the entire area had normal hair re-growth;

Figs. 7a to 7d show the Cat of Example 8;

Fig 8 shows the cat of Example 9;

Fig. 9a and 9b show the results of the non-nosode homeopathic treatment on the IgG levels in a group of Lactating Holstein Cows for Subclinical Mastitis. Based on these results there is an effect even with out the inclusion of nosodes of Example 10;

Figs. 10a to 10c show the dog of Example 11 ;

Figs. 11a to 11b show the cat of Example 16;

Figs 12a and 12b show the dog of Example 17; and

Figures 13a to 13f shows the cat of Example 20.

Examples

GENERAL METHODOLOGY

The general methodology in the following examples, in particular in examples 1 to 9, was to select patients where recovery was not expected despite having been treated with conventional treatments and there was no other conventional treatment to use. Thus, patients who received the homeopathic compositions according to the invention were selected as described on the basis of a non-response to conventional therapy.

MATERIALS

Unless otherwise stated, it will be understood that each homeopathic ingredient is combined in approximate equal proportions from approximately 0.1% to 20% v/v based on the volume to of the total homeopathic complex.

Also unless otherwise stated, homeopathic complexes for topical use, in the forms of creams, are generally in the low potency range, from for example mother tincture to approximately 18x/9c. For internal use, for example as a liquid composition, the homeopathic ingredients are generally of the high potency range from 30 plus, preferably 200c plus.

- -

Finally and unless otherwise stated, when used as a cream, the homeopathic complex is generally combined with a base comprising approximately 25% Lanolin, approximately 50% approximately Petroleum with 25% Mineral oil. When used as a liquid the homeopathic complex is generally administered in alcohol and water, for example 20% ethyl alcohol and 80% purified water or 30-40% glycerine and 70% purified water. Alternative bases and carriers, as expanded in the specific Examples following, include topical antibiotics and Aloe Vera Veterinary spray.

The following complexes, defined in Cores A to D. were used in the Examples 1 to 9.

Core A Ingredients

Hepar sulphuris calcareum [Hep] ; Lachesis muta [Lach]; Mercurius Solubilis [Merc] and Silica [SiI].

These are the essential anti-infective/anti sepsis ingredients. It will be understood that Lachesis may be replaced or complemented with many snake or spider remedies which have a similar septic shock profiles e.g. Crotalidae (crotalus

Horridalus) and Tarentula Cubensis.

Core B Ingredients

Aconite napellus [Aeon]

Arnica montana [Arn] Arsenicum iodatum [Ars-i]

Belladonna [Bell]

BeINs perennis [Bell-p]

Bryonia alba [Bry]

Calenula Offcinalis [Calen] Chamomilla Matricaria [Cham]

Echinacea angustifolia [Echi]

Echinacea purpurea [Echi-p]

Graphites naturalis [Graph]

Hamamelis virginiana [Ham] Hypericum Perforatum [Hyper]

_ _

Ledum palustre [Led] Millefolium achillea [Mill] Phytolacca decandra [Phyt] Rhus Toxicodendron[Rhus-T] Ruta Graveolans [Ruta] Stellaria media [Stel] Sulphur[Sulph]

Symphytum officinale [Symph] Thuja Occidentalis[Thuj]

Additional Core B ingredients, Conium maculatum [Con] and Gunpowder [Gunp], were used in Examples 1 to 9 only.

Core C Ingredients

Arsenicum album [Ars]

Apis mellifica [Apis]

Astragalus membranaceus [Astra-mem.]

Baptisia tinctoria [Bapt] Bufo rana [Bufo]

Carbo vegetabilis [Carb-v]

Calcarea carbonica [CaIc]

Calcarea fluorica [Calc-f]

Calcarea phosphorica [Calc-p] Gelsemium sempervirens [Gels] lodium purum [lod]

Ipecacuanha [Ip]

Kali iodatum [Kali-i]

Lac caninum [Lac-c] Lac Bovinum Lac Vaccinum (cow)

Lycopodium clavatum[Lyc]

Nux vomica [Nux-v]

Phosphorus [Phos]

Pulsatilla nigricans [PuIs] Pyrogen [Pyrog]

_ _

Sabal serrulata [Sabal] Sepia succus [Sep] Staphysagria [Staph] Urtica urens [Urt-u] Zincum metallicum [Zinc]

Core D Ingredients

Adrenalin [Adren]

Aesculus hippocastanum [Aesc] Baryta carbonica [Bar-c]

Caladium seguinum [Calad]

Cantharis vesicatoria[Canth]

Cocculus indicus [Cocc]

Histaminium (Histamine) [Hist] Hydrastis canadensis [Hydr]

Lavender [Lav-v.]

Mezereum [Mez]

Nitric acid [Nit-ac]

Paeonia Officinalis[Paeon] Prednisolone [Predni.]

Ranunculus bulbosus [Ran-b]

Rumex crispus [Rumx]

Thiosinaminum [Thiosin]

Sol [Sol]

Optional Nosodes

Nosodes are ideally selected from Tuberculinum bovinum, Tuberculinium aviaire,

Staphylococcus aureus, Strepococcus, Corynebacterium, E. CoIi, Colibacillinum,

Bacillinum and/or Medorrhinum.

The following complex was used in Example 10.

This treatment essentially comprises, Core A, Core B minus graphites, millefolium and thuja and Core C minus Arsenicum, Gelsemium and Staphysagria, plus Conium.

- -

- -

- -

- -

The following optional nosodes may also be added, at a preferred potency of 3OC to 1 M and a 1 :1 ratio of each ingredient : Tuberculinum Bovinum, Tuberculinium Aviaire, Staphylococcus Aureus, Strepococcus, Strepococcus Mix, Corynebacterium, E. CoIi (ColibacillinuM), Bacillinum and Medorrhinum at a preferred potency of 3OC. E. CoIi was added at a preferred potency of 200C.

The following homeopathic complexes were used in Examples 11 to 20.

Vet cream

This treatment essentially comprises, Core A and Core B with graphites, sulphur and thuja (the optional Core B ingredients).

Each homeopathic ingredient was combined in approximate equal proportions based on the volume to of the total homeopathic complex and administered as a cream with a base comprising approximately 25% Lanolin, approximately 50% approximately Petroleum with 25% Mineral oil.

Mastitis Treatment

This treatment essentially comprises, Core A and Core B with optional ingredients thuja, sulphur and graphites and additional ingredients Urtica, Gunpowder and Conium. The addition of Gunpowder is optional and depends on Regulatory Rules.

Each homeopathic ingredient was combined in approximate equal proportions based on the volume to of the total homeopathic complex and administered as a cream with a base comprising approximately 25% Lanolin, approximately 50% approximately Petroleum with 25% Minerai oii.

- -

- -

Trauma/First Aid treatment

Each homeopathic ingredient below was combined in approximate equal proportions based on the volume to of the total homeopathic complex and administered as a liquid in alcohol and water, for example 20% ethyl alcohol and 80% purified water.

- -

EXAMPLE 1

Subject - Springer Spaniel Female neutered, age 5 years old on Day 0.

Condition/Symptoms of Subject

- The patient presented with non-healing wound of what appeared to be a MRSA-type infection resulting from minor surgical wound as a result of elective surgery in the area of the stopper pad. The owner described the original wound as having been completely closed after surgery.

- The patient had an ulcerative skin lesion which had started after minor surgery and had gradually extended.

- There had been no response to repeatedly changed conventional antibiotics (Fuciderm®) or the antibiotic impregnated dressings used

- After using a number of conventional antibacterial therapeutics the owner had decided to try an alternative approach.

Treatment On Day 0 the patient was taken off all oral conventional medication. A cream consisting of Core A and Core B with the addition Fucidin was applied by mixing a tube of Topical Ophthalmic Antibiotic FUCITHALMIC® Viscous Eye Drops (1% fusidic acid). The Cream was applied to the affected area generously and the area bandaged up with cotton wool and an elastic self adhesive bandage and covered with an elastic adhesive bandage. Four days later, a very substantial improvement in the patient's condition was observed. Treatment with just a cream consisting of core A and core B was then repeated without the addition of the Fucidin. The patient was next seen in 5 months later and the treatment had been successful.

Conclusion

_ .

The dramatic and unexpected response in this subject confirms what has been seen in many other patients that the homeopathic complex of the invention work. There are no reported side effects, toxicity, administration was easy and the effectiveness in this species was dramatic and successful.

The homeopathic complex of the invention comprising Core A and Core B work when co-administered with conventional therapeutics, when the conventional therapeutic (antibiotic) did not work on its own. It shows the synergy with conventional therapy with no negative interaction

This example also indicates that the homeopathic complex of the invention is capable of saving lives as in the case of this subject where it was non-responsive before treatment, with the potential of having a limb amputated if the condition had continued to progress as it had been, not only did it save the subject from an amputation with possible similar consequences, but it restored the limb to full normality completely healing the ulcers

EXAMPLE 2

Subject - Feline male neutered of indeterminate age

Conditions/Symptoms of Subject

The subject originally presented as a post road traffic accident patient, with multiple traumatic skin injuries and multiple fractures of the left femur the latter were repaired by open reduction and intramedullary pining. The fracture site had to be partially re- broken as there was already cartilaginous callus repair with very mal-aligned bone fragments.

The subject was post shock. It was already in the healing phase of injury, but the wounds were still open and fresh. The bone fractures were attempting to heal out of alignment. The subject was initially unable to walk on the hind legs despite having one un-fractured leg. The musculature bones and wounds were all painful. The wounds were due to grazing probably from contact with a road surface and so friction burns as well as wounds, bruising and fractures were present.

_ _

Treatment

The fractures were treated by open reduction. Immediately post surgery the patient was administered a 0.21ml liquid dropper dose of a complex of Cores A, B and C combined in an excipient of 20% ethyl alcohol and 80% purified water. This was given on a first aid basis to aid recovery and promote rapid healing. Subsequently, a cream comprising Core A and B for topical application in a base carrier of 25% Lanolin and 50% white petroleum at 2oz/lb and 25% mineral oil with the homeopathic combination added at 3.33% Vol/Vol (3.33ml/100ml) w/w (3.33g/100g) was applied topically to all wounds and known bruised regions including the surgical wound particularly over the fracture site. Antibiotic cover was provided by Crystapen into the surgical wound and parental Amoxycillin and Clavulanic Acid (Synulox Pfizer), but would not explain the rapidity of recovery other than the absence of infection.

Result

Figure 1a shows the subject of Example 2 pre-treatment and figure 1b shows the subject of Example 2 after a 24 hour of treatment.

The results were dramatic with the patient walking to obtain food within 48 hours of the surgery. Not only that but as pictures Figure 1a and Figure 1b show the rate at which healing progressed in this patient with the gap between photographs of the same wound being of the order of 24 hours. All wounds had completely resolved in a 10 day period.

Conclusion

This case shows the unexpected rapidity of wound, fracture and injury resolution brought about by the use of the Cream with Core A and B combined topically and the oral administration of just a single unrepeated dose of Core A, B and C in a liquid dose form.

It once again shows the synergy with conventional therapy with no negative interaction. Once again there were no reported side effects, toxicity, administration was easy and the effectiveness in a different species to Example 1 was just as dramatic and successful

EXAMPLE 3(a)

Subject - "Sambo" Equine Gelding 14 -16 years old

Conditions/Symptoms of Subject

- Subjects, "Sambo" Equine Gelding 14 -16 years old and a piebald mare, presented with acute severe photo-dermatitis due to sun over-exposure.

- All the un-pigmented skin on the nose was suffering from severe solar radiation burns (Fig 2a) - The skin on the nose was sunburnt, oozing, scabby, cracked, and painful to movement and touch. There were also patches of sloughing.

Treatment

A cream comprising Core A and B for topical application in a base carrier of 25% Lanolin and 50% White Petroleum at 2oz/lb and 25% mineral oil with the homeopathic combination added at 3.33% (3.33ml/100ml) was applied topically on a twice daily basis for 5 days to the affected areas of the subject and then once daily due to the rapidity of improvement.

Results

Figure 2a was taken on day one with figure 2b taken 11 days later. The homeopathic complex used promoted rapid healing and also conferred some form of resistance to further sunburn or sun sensitivity

This protocol has been repeated with other horses with exactly similar results. In one patient so severe was the reaction that the glands on the neck swelled up in acute response. The affected area was so sore cream could only be applied around the affected area. However, a similar response was achieved.

Conclusion

Previous cases of equine photo-dermatitis had taken between 3 months in mild cases, to 6 months in similarly severe cases to recover and then in many cases

. .

residual scarring was present. This case shows the unexpected rapidity of burn resolution brought about by the use of a topical cream with Core A and B.

Example 3(b)

Subject - Herd of male and female pigs less than 1 year of age

Conditions/Symptoms of Subject Subjects were presented with acute severe photo-dermatitis after being left out on new pasture during a period of unbroken sunshine. The subjects presented much as a case of bad human sunburn would (Figure 3a) with the whole patient having a bright red burning hot inflamed tender skin with crusting of the skin at the worst affected areas where there was deep cracking due to third degree burning. There were areas of peeling and scabbing of the affected skin.

Treatment

Due to success with previous cases in a range of other species a treatment with Core A and Core B combined was used. However, due to the number of animals a novel delivery method was required. Aloe Vera Veterinary Spray (Forever Living Products) was used as a carrier for Core A and Core B. Once daily spraying of the carrier with Core A and Core B was decided upon with a second spray when possible at feeding time.

Result

A complete and total resolution of all the symptoms of severe sunburn leaving normal healed skin was achieved in 10 days and this change is shown in Figure 3b. The skin is normal pink and healthy with no signs that would normally be expected with this degree of sunburn having been present 10 days earlier. This similar to Example 3a the improvement and healing was achieved in a very short time period.

Conclusion

This case shows yet again the unexpected rapidity of burn resolution brought about by the use of the Cream with Core and Core B combined topically. In addition, it demonstrates both the healing properties of the invention and the anti-sepsis

properties of the Cores (none of the burns in the group became infected despite the muck, dirt and flies that were present). Additionally, the homeopathic complex minimized scarring. Furthermore, the homeopathic complex may be used with groups, herd, flocks etc.

EXAMPLE 4

Subject - Cavalier King Charles Female - not neutered age 3 ¹ A years old.

Conditions/Symptoms of Subject

Patient presented with acute mastitis. Initial examination showed the patient to have a temperature in excess of 104 ^Q F/ 40 ⁵ C. The mammary glands were hard swollen and in danger of gangrene on assessment. The patient was treated with a combined homeopathic and conventional therapy.

Treatment

As the condition was acute severe and life threatening, it was decided to treat with a combination of homeopathic and conventional therapy.

An initial injection of Synulox® (Amoxycillin Trihyd, Clavulanic Acid) at a dose of 1 ml SC and Clamoxyl LA® (Amoxycillin Trihyd ) at a dose of 2ml SC and an oral dose of 15 drops of Cores A, B and C with nosodes at dose of 0.07ml/drop which was approximately 1ml liquid dropper dose of complex of Cores A, B and C combined in an excipient of 20% ethyl alcohol and 80% purified water to act as an anti-infective was administered as a single initial dose. Topical application of a cream comprising Core A and B for topical application in a base carrier of 25% Lanolin and 50% white Petroleum at 2oz/lb and 25% Mineral oil with the homeopathic combination added at 3.33% (3.33ml/100ml) was also carried out. The patient was checked the following day and the mammary glands as evidenced in the picture below had virtually returned to normal. The owner was told to complete the antibiotic course to prevent any resistance developing.

Results and Conclusion

The owner reported that by the time the dog got home some 15 minutes after being given the Cores A, B and C orally as a liquid preparation and having topically applied a cream with Cores A and B the subject had already started to improve.

Figure 4 shows the subject within 24 hours of the start of treatment. The patient was checked the following day and the mammary glands had virtually returned to normal within a 24 hour period. The owner was told to complete the antibiotic course to prevent any resistance developing.

Conclusion

This example demonstrates the synergy of the homeopathic complex of the invention and correctly chosen conventional pharmacotherapy, an antibiotic in this case. It demonstrates the speed of action of this invention as some 15 minutes after initiation of therapy there had been an improvement and within 24 hours there appeared to be almost complete resolution of the mastitis, which was severe and septic in nature. It demonstrates that this medication is capable of speeding the resolution of a very severe case of acute sepsis in conjunction with conventional therapy.

EXAMPLE 5

Subject - Canine Collie Cross Male 1 Year old

Conditions/Symptoms of Subject

- Subject presented with several skin reaction (around nose area) to hogweed or other related plants (Figure 5 (a) before (b) after ).

- The skin had vesicles which were intensely itchy and were oozing serum as a result of intense puritus.

Treatment

Twice daily topical treatment with cores A and B and oral treatment with modulator Rannunculus Bulbosa, Sol 30c from core D.

_ _

Core A and B were administered as a cream in a buffered cream base carrier of Purified water BP ₁ Soft White Paraffin BP, Dehydag Wax, Liquid Paraffin BP, DiSodium Hydrogen Phosphate BP Citric Acid BP and Chlorocresol BP for Core D modulators added at 3.33% and combined and 50% White Petroleum at 2oz/lb and 25% Mineral oil with the homeopathic combination added at 3.33% (3.33ml/100ml).

Rhus Tox and Urtica Urens 6c were also administered with Core A and Core B.

Result Condition disappeared after homeopathic complex administration

Conclusion

This example demonstrates the antipuritic and anti-inflammatory as well as the wound resolution capabilities of the homeopathic complex. Both plant chemical burns and auto-immune conditions are generally very difficult to resolve even over a prolonged period often leaving severe scarring or a constantly recurrent condition. The resolution of this case alone was unexpected without having a protracted treatment period with considerable scaring.

This example also demonstrates the speed, efficacy, safety (as dogs continually lick off the cream in this location) and ease of use where the condition was painful and puritic and yet was alleviated on administration of the cream.

EXAMPLE 6

Wound Healing Case Study - Wound Closure of a chronically infected non healing wound

Subject - Bichon male neutered 6 years old.

Conditions/Symptoms of Subject

The subject presented with severe damage to tissues of the leg where there were areas of necrotic tissue that sloughed leaving even more exposed areas. The patient presented with a suspected hairline fracture of a digit. The leg was severely wounded and was bandaged.

The patient was already on antibiotic therapy and there was antibiotic dressing on the wounds. The owner sought a second opinion on the basis that the wound smelled strongly offensive, the patient was much more tender and lame on the affected leg. Figure 6a gives a very accurate idea of the condition the leg was in when the dressing was removed initially, although the picture was taken after ten days of treatment following the initial second opinion consultation

Treatment Initial treatment was with antibitiotics Synulox® 250mg composition (200 mg amoxicillin and 50 mg clavulanic acid) was given orally at a dose of Vz tablet twice daily for 7 days along with Metronidazole 200mg Vfe tablet twice daily for 7 days. The wound was left open. At this point due to lack of progress the antibiotic was changed to Lincocin (Antirobe 50mg) 1 tablet twice daily. Calendula 6c was given orally three times daily to try promote healing. Although the wound no longer smelled, its healing had failed to progress at all.

It was decided at this point to abandon systemic antibiotic therapy to treat the wound. The patient was anaesthetised using ACP2mg/ml as a premed .05ml IM, Thiopentone 2.5% IV as a knockdown anaesthetic and maintained on Isoflourane. A swab was taken for culture at this point despite antibiotic therapy, as it was hoped that it might give some indication of a suitable treatment. The area around the wound was clipped and tension sutures placed in the wound which failed to provide reasonable apposition but did reduce some of the wound size. The wound was once again washed with Hibiscrub Surgical Wash, followed by povodine Iodine surgical scrub and then rinsed with saline and then bathed in sterile water with Homeopathic Mother tincture of Calendula (Marigold) at a dilution of 20 drops of mother tincture add to 100ml of sterile water. The wound was then allowed to dry fully and a cream comprising Core A and B for topical application in a base carrier of 25% Lanolin and 50% White Petroleum at 2oz/lb and 25% Mineral oil with the homeopathic combination added at 3.33% (3.33ml/100ml). The cream was to be applied to the open wound 2 to 3 times daily. All antibiotic therapy was discontinued. The most open upper part of the wound had tension sutures placed in it to draw the edges somewhat closer together. This was to be followed by the application of the cream as described as the wound still remained very open.

_

Within 10 days as in the previous examples a huge amount of healing had taken place with the photograph Fig 6b showing the change at day 12. Within 30 days the wound was completely healed and only a thin scar remained (Hg 6c) and within a year the scar was virtually completely gone and almost the entire area had normal hair re-growth (fig 6d)

RESULT

20 days after the initial injury and just 7 days after starting treatment the healing results were amazing the odour was completely gone the skin and wound showed a dramatic healing even in the area where the skin was black and hard it had gone soft and pink.

Three weeks later, the wound is fully closed, clean with hair re-growth.

CONCLUSION

The homeopathic complex when applied to this wound acted as an anti-infective as antibiotic therapy was terminated when therapy with the cream comprising Core A and B was initiated in addition to this the rate of wound healing and resolution was dramatically accelerated as shown in Figures 6(a-d). The end result was an almost total return to normal of the affected area, a dramatic result by any standards.

This example demonstrates the true extent of action of Core A and B when used on their own in a cream delivery system to a wound with indolent healing features as in this case where after over 10 days there was no sign of granulation or healing in the wound yet with the introduction of the invention the wound which was large and non healing suddenly started to show accelerated healing.

It also demonstrated that this invention acts with similar efficacy across many different types of wound and skin condition a very unique feature. It demonstrates the usefulness of the invention with septic wounds and particularly those with antibiotic resistant infections (Multi-resistant Infections) as in this wound a range of antibiotics had been used with no resolution of the wound. The prolonged nature of the treatment also demonstrated the safety and lack of toxicity or side effects of the invention as the owner continued to apply the cream sparingly to the affected area for

months till almost any signs of scarring let alone the wound had resolved. It also shows how well tolerated the invention is in this format - despite how painful, raw and sensitive the area was the owner was able to apply the invention several times a day.

EXAMPLE 7(a)

Subject - Human 31 year old Lactating female.

Conditions/Symptoms of Subject

- The subject a 31 year old female developed a complaint of sore swollen painful breasts associated with the breast feeding of her second child.

- The symptoms began to appear within 10 days of leaving the hospital post birthing.

- The glands were swollen and painful to the touch, the breasts were engorged with milk and the patient complained that breast feeding was difficult at best. There had been no previous history of any mammary gland infection with the pervious child birth. A diagnosis of post birthing mastitis was given and a course of antibiotics were prescribed by the treating physician. After several days the patient still had no relief and began to seek alternative options.

Treatment The patient began treatment with oral dosing of the homeopathic medication complex for mastitis comprising Cores A, B and C (no nosodes) in dropper dose in an excipient of 20% ethyl alcohol and 80% purified water twice daily with the product being sprayed onto the oral mucosa 13 days post birthing.

Result

Relief was established within 24 hours and a total elimination of symptoms in 48 hours. There has been no re-occurrence of the condition or symptoms since treatment

.

EXAMPLE 7(b)

Subject - Human 30 year old Lactating female.

Conditions/Symptoms of Subject

A 30 year old white female was presented with health concerns that arose 4 days after leaving hospital after giving birth to a female child. The patient was in hospital for 3 days and the condition did not manifest until 4 days post hospital. This was a second child and the patient did not have a history of mastitis- mammary gland infections.

Symptoms included a high fever, painfully swollen mammary glands with pain extending under left arm. Breasts were extremely painful to the touch and breast feeding was problematic at best. General movement was also guarded due to the inflammation and pain associated with movement.

TREATMENT

Three sprays, 2ml, of the liquid homeopathic medication complex for mastitis comprising Cores A, B and C (no nosdoes) in dropper dose in an excipient of 20% ethyl alcohol and 80% purified water was administered by the subject 3 times daily for 2 days based on the nature of the condition and the lack of response to antibiotic therapy on its own.

RESULT Pain was reduced after 3 hours, inflammation was reduced within 24 hours and a total resolution was achieved in 48 hours.

CONCLUSION

The response confirmed that Cores A to C work as an anti-infective and anti- inflammatory in humans. It demonstrates a rapid response in humans to the invention and that the invention is safe and side effect free in humans.

It shows that the use of Cores A to C internally (this can also be delivered transdermal^, orally, perivaginally or parentrally) demonstrates a consistent response as a potent anti-infective agent.

EXAMPLE 7(c)

Subject - Human Male 60+year

Conditions/Symptoms of Subject

Subject was diagnosed with meningioma and had surgery to remove the same. As follow up radiation therapy was done 5 days a week for 6 weeks. The subject presented with itching and soreness of the skin over the area of radiotherapy, a known consequence of radiotherapy.

Treatment

The invention was provided in the form of a cream comprising Core A and B for topical application in a base carrier of 25% Lanolin and 50% White Petroleum at 2oz/lb and 25% Mineral oil with the homeopathic combination added at 3.33% (3.33ml/100ml). The cream was to be applied to when the skin was itchy and sore after radiotherapy on an as needed basis.

Result

As soon as the patient applied the cream the skin conditions were relieved. The patient was able to complete the radiotherapy course with simple easy to apply relief when required

Conclusion

Core A and Core B formulated as a cream works in humans similar to animals and this is one of a series of similar cases all with similar positive results. The invention has a rapid and immediate effect. The invention is effective in treating burns, burn wounds, itch, soreness and radiation burns.

EXAMPLE 8

Wound Healing Case Study - Septic post surgical mastectomy wound healing

Subject - Tabby and White Domestic Short Haired Cat Female Not Neutered estimated age 6-7 months

Conditions/Symptoms of Subject The subject presented as a second opinion case where a unilateral mastectomy had been carried out due to gangrenous mastitis. The subject had had the surgery a little less than a week previous to being brought to us, all her kittens had died prior to the mother arriving with us from a combination or the initial malnutrition and sepsis from the mastitic milk. Thus only the mother was presented and she had continued to deteriorate during the post surgical period much as had occurred with the kittens. The subject presented with a fever of T103.5 ^Q F on 25 ^th April 2007 and was already on Convenia a 14 day duration antibiotic active ingredient Cefovecin a cephalosporin and was failing to improve. The patient was in appetent and a large area of tissue was still on the point of sloughing. The initial presentation was fairly dramatic with a lack of response to conventional medications (Figures 7a to 7d).

Treatment

The subject was given twice daily oral dosing with 5 drops or .35ml of the delivery dose was administered by mouth twice daily. The delivery dose comprised of Cores A, B and C with the following Nosodes: Tuberculinum Bovinum, Tuberculinium Aviaire, Staphylococcus Aureus, Strepococcus .Strepococcus Mix,

Corynebacterium, E. CoIi (ColibacillinuM) ,E. CoIi, Bacillinum and Medorrhinum, in a liquid dropper. Cores A, B and C with Nosodes were combined and added at a rate of .07ml /ml in an excipient in glycerine 30% with purified water to act as an anti- infective. In addition cream comprising Core A and B for topical application in a base carrier of 25% Lanolin and 50% White Petroleum at 2oz/lb and 25% Mineral oil with the homeopathic combination added at 3.33% (3.33ml/100ml). The cream was to be applied to the open wound 2 to 3 times daily. All antibiotic therapy was discontinued.

Result

Within 24 hours the non responsive subject had a decrease in it pyrexia from T103.5 ^s F to T102.2 ^s F and had started eating. The patient has also started drinking again, the wound still looked appalling, but had a less putrid odour Fig 7a and within in 3 days the patient had improved dramatically with the gangrenous area having

sloughed and healing had started to rapidly occur in the affected area the cat was now eating, drinking, walking around and purring again.

Within 7 days the entire wound area was dry an all oozing gone due to the rapid rate of healing the fact that the patient had previously been under general anaesthesia for the original surgery and non responsive treatment we decided to allow the wound to heal by second intention.

Fig 7c - ten days after initiating treatment the patients wound had reduced in surface area sufficiently for some areas of the wound to have started to close showing no trace scarring.

Fig 7d - at the three week stage healing was virtually complete and the patient sent home. Further reports on the subject is that it continues to do well and no one would know the problem was ever there

Conclusion

The homeopathic complexes administered are effective in the presence of resistant infection not susceptible to previously chosen antibiotic cover and produce a rapid response with a fast drop in temperature showing the invention acting as an antipyretic. The invention is safe as there were no side effects seen where the invention was applied both internally and externally over a large surface area for a prolonged period in a subject. The invention act as a potent anti-infective composition. The invention promotes wound healing even in very large septic wounds. The invention can be co-administered with antibiotics. The invention is non-toxic, the subject being a cat continually washed the cream off its coat for the entire duration of treatment and showed no ill effects. The invention has anti-inflammatory and analgesic properties as the subject was rapidly able to get up and walk around. The invention is easy to use due to the above the subject allowed easy administration of the invention to area that were obviously sore. The invention can be administered by multiple routes and by multiple delivery methods.

EXAMPLE 9 Wound Healing Case Study - Treatment of Mastitis and Mammary Hypertrophy

. .

Subject - Domestic Short Haired Cat F <2years

Conditions/Symptoms of Subject The subject had already received treatment before being brought for a second opinion. The subject had already been given Convenia, a 14 day duration antibiotic with active ingredient Cefovecin (a cephalosporin), and had failed to improve over the subsequent treatment period and had in fact got worse with the mammary glands continuing to increase in size and discolouration, the patient had become lethargic and in-appetent, but still continued to eat some food.

The subject presented with massive mammary hypertrophy and a history of what was diagnosed as mastitis. Fig. 8a shows the degree to which the mammary glands were enlarge discoloured. Fig. 8b shows the ball that was placed between the glands as a reference to show the true size of the gland swelling.

Treatment

The subject was given twice daily oral dosing with 5 drops or .35ml of the delivery dose was administered by mouth twice daily. The delivery dose comprised of Cores A, B and C with Nosodes as per Example 8 in a liquid dropper. Cores A, B and C with Nosodes were combined and added at a rate of .07ml /ml in an excipient in glycerine 30% with 70% purified water to act as an anti-infective. In addition cream comprising Core A and B for topical application in a base carrier of 25% Lanolin and 50% White Petroleum at 2oz/lb and 25% Mineral oil with the homeopathic combination added at 3.33% (3.33ml/100ml). The cream was to be applied to the entire mammary are 2 to 3 times daily. All antibiotic therapy was discontinued.

Result

Within 10 days there was complete resolution of the condition the speed and rapidity of which is evidenced when one compares Fig 8a and Fig 8b. The glands which were sufficiently large to hold the ball between them and were much larger than the 1.5cm ball had within 10 days returned to an almost flat in active state. A remarkable change considering the starting point and the lack of response to previous therapies

Conclusion

_ _

Thus, the homeopathic complex of the invention is effective in the presence of resistant infection not susceptible to previously chosen antibiotic cover and produces a rapid response with a rapid reduction in size of the affected mammary glands on a daily basis.

The invention is safe as there were no side effects seen where the invention was applied both internally and externally over a large surface area for a prolonged period in a subject. The invention is non toxic.

The homeopathic composition of the invention act as an effect anti-infective in cases of mastitis which is both complementary and synergistic with conventional medication and promotes healing as demonstrated in this Example.

The invention can be co-administered with antibiotics.

Furthermore, conventional treatments for mastitis and mammary hypertrophy did not achieve the same effect and the nine day return to normal of the patient in this example was exceptionally rapid. The authors note a case where the hypertrophy had been present for 8-12 weeks and after starting after an injection of delvosterone had continued to get larger on a daily basis until Delvosterone11c was given. In this case the reduction was slower and damage took longer to heal.

Example 10 Homeopathic Therapy Evaluation for Subclinical Mastitis in Lactating Holstein Cows

Field trial were carried out using an anti-infective homeopathic complex

Materials:

The Mastitis treatment was administered as defined in the General materials section. Nosodes were not included for the purposes of this trial.

_ _

The homeopathic ingredients were extracted in 95% ethanol (USP, BP, EP) and 10% triple distilled water. The following carrier was used for the resultant homeopathic complex 20% ethanol and 80% purified water.

Objective:

The objective of this study was to evaluate the effect of the homeopathic treatment above, on somatic cell counts and immune status of cows.

Introduction: High somatic cell counts (SCC) in milk are the primary indicator of an infection in the mammary gland and intramammary infections result in reduced milk production and lower quality of milk. Elevated somatic cell counts can be the result of a clinical or sub-clinical infection or, in some cases, SCC may be elevated in the absence of a pathogenic organism. Generally, if a cow exhibits clinical mastitis, then this cow is treated with an antibiotic, by intramammary infusion or systemically, depending on the severity of the clinical signs. If a sub-clinical infection is determined from a microbial culture of the milk, the cow is monitored but not treated until the end of lactation, since treatment of these cases during lactation is not usually effective. Treatment at dry-off has been established to be the most effective treatment for a sub-clinical mastitis infection. Sub-clinical infections result in reduced milk production that can be a loss of several thousand dollars per animal per lactation. In addition, elevated SCC results in the loss of quality premiums for producers. Therefore, reducing SCC and sub-clinical infections are beneficial for both animal health and profitability. Alternative treatments, including homeopathic treatments, have been suggested as effective treatments for sub-clinical mastitis or other health concerns for dairy cows. However, these products have not been adequately researched under controlled study conditions and the only information available is from testimonial reports and studies conducted by the industry that did not have appropriate controls and have not been published. It is unknown if the product, Mastoblast, is effective in reducing SCC and if the product can reduce the incidence of intramammary sub-clinical infections.

Protocol:

Twenty-four lactating cows from the University of Connecticut diary herd were selected based on the pattern of somatic cell counts in milk and the presence of a mastitis pathogen (sub-clinically infected) from the June 27, 2000 CT Mastitis Laboratory. Animals were then paired by SCC, infection status, age and stage of lactation and randomly assigned to one of the two treatments within classes of infection status.

Treatment design was follows:

Treatment A Mastitis treatment

6 cows with positive cultures (if possible) 6 cows with negative cultures

Treatment B Control treatment

6 cows with positive cultures (if possible) 6 cows with negative cultures

Cows were housed separately by treatment group within the Kellogg Dairy Centre throughout the study period.

Cows were aseptically cultured at day -3 and day -1 and day 3 to verify the intramammary infection status and SCC and at least nine cows will be assigned to each treatment. The homeopathic treatment and control treatment were administered as a spray on the nasal membranes for 10 days starting at day 5. Starting at day 2, milk was sampled from the afternoon milking for SCC analysis every three days for two weeks. Thereafter, milk was sampled for SCC once weekly through 8 weeks. Milk was sampled aseptically for pathogen analysis on a two-week basis up to 10 weeks. Daily milk production was recorded. Monthly milk fat and protein content was determined from DHI testing. Blood, from veni-puncture and milk samples was collected from each animal at twice per week to measure differential counts of white blood cells to assess immune status in the cows. Effect of the treatment on SCC, milk production and immune status was analyzed by ANOVA and the GLM procedure of SAS.

- -

Materials and Methodology

Study methodology

The study was 60 days in length. At day 1 , foremilk was aseptically collected from each quarter of all cows and analyzed for mastitis pathogens at the University of Connecticut Mastitis Laboratory and bacteriological status of milk samples was determined by diagnostic procedures recommended by the National Mastitis Council (1987). Milk was then sampled from the total milking of each cow on day — 1 and analyzed for SCC (Marshall, 1992) and for the immunoglobulins Gi (IgG ₁ ) using ELISA quantitation kits (Bethyl Laboratories, Inc; Montgomery, TX). These values provided baseline nonspecific estimates of the intramammary infection status of each quarter and the immune system status.

On day 1 through day 10, the homeopathic therapy and the placebo were administered twice daily before each milking. On days 3, 7, 10, 13, 16, 22, 28, 35, 42, 49, and 56 milk was sampled and analyzed for SCC. On days 3, 13, 22, 28, 35, 42,49 and 56 the milk samples were also analyzed for IgGL In addition, on days 28 and 56, foremilk from each quarter for all cows was aseptically collected and analyzed for mastitis pathogen as described earlier. If a cow developed clinical mastitis, the data from that cow were removed from the analysis due to marked increases in SCC and immunoglobulins due to clinical mastitis that may bias the analysis. In this study, the sample size was not large enough to accurately determine treatment differences for clinical mastitis, because clinical mastitis is usually a low incidence disease.

- -

Results

These results show significant effects for IgGI only. The IgGI is the only immunoglobulin to show significant change the lgG2 section was affected by the cattle not receiving homeopathy developing mastitis and having to be removed from the trial. This factor was not part of the trial results as it was not part of the parameters to be examined, but the actual incidence of mastitis in the animals not receiving the homeopathic medication was much higher than those who received the homeopathic medication. The change in the significant changes in IgGI may have been related to the reduced incidence of mastitis. The lack of change in lgG2 may have been related to the masking of this effect by the intrusion of clinical mastitis into the trial in the non homeopathic group - without this there may also have been a change in lgG2. Both IgG's have been associated with mastitis and conferring protection against mastitis in cattle (see Figs 9a and 9b).

Conclusion

We found that he actual incidence of mastitis in the animals not receiving the homeopathic medication was much higher than those who received the homeopathic medication. Thus, the conclusion is that an effect in IgGI was seen while the animals were on homeopathic treatment.

EXAMPLE 11

Wound Healing Case Study - Accelerated Wound Closure and Healing

Subject: Jack Terrier, male neutered, 10 years old

Conditions/Symptoms of Subject

The patient presented in shock with multiple bite wounds, which were acutely painful, with difficulty in breathing and the danger of an injured trachea temporarily ruled out treatment under general anaesthesia.

Examination of the wounds revealed that the bites had penetrated through the skin to cause substantial damage to the underlying muscles at the junction of the neck and chest between the axillae, around the dorsal aspect of the left foreleg, and over the rib cage on the left side.

Treatment

Initial therapy included clipping the wounded area and washing the skin margins with Hibiscrub surgical scrub followed by povidone iodine. The open wound was then bathed in sterile water with Homeopathic Mother tincture of Calendula (Marigold), at a dilution of 20 drops of mother tincture add to 100ml of sterile water. The wound was gently dabbed dry and Vet Cream (Core A and Core B in the form of a cream) was liberally applied to the entire affected area and the surrounding tissue close to the wound margin. The owner was instructed to apply the cream to the affected area 2-3 times daily.

When wound treatment was complete the patient was given a single 15 drop dose of Trauma/First Aide Complex. Antibiotic cover was instigated with a single 0.5ml intramuscular injection of Synulox RTU (Pfizer Animal Health). Maintenance of antibiotic cover was supplied by Synulox 250mg tablets (Pfizer) at a dose rate of Vz a tablet twice daily for 5 days.

Results

Two days after the initial consultation the tissue around the wounds was obviously bruised, but dramatically less. The painful breathing initially apparent on the day of presentation was considerably better and the fluid from the underlying lacerated

muscle layer was draining from the wounds. A decision was taken not to suture the wounds weighing up the benefits of the drainage as well as the absence of sepsis and the dramatic decrease in pain.

Seven days after the initial attack, the wounds were already closing over and there was no evidence of bruising or local skin damage (see Figs 10a to 10c).

Conclusion

The rapidity of healing is very clear where there is a total disappearance of tissue bruising and all surface injuries, other than the major wound points, had literally vanished. In the same period the wound holes themselves had produced healing edges and had filled in the open areas completely. In general with wounds like this one expects sepsis or at the very least a large amount of tissue swelling and bruising that lasts some weeks and that a drain might be required. In a patient with no anti- inflammatory or analgesic treatment (as in this case) one would not normally have expected the patient to be fully mobile in two days.

EXAMPLE 12

Wound Healing Case - Bite wound Healing

Conditions/Symptoms of Subject

The patient (canine) originally presented with what was thought to be a self inflicted skin condition from scratching, described as hair coming off with scabby eruptions.

However, on further examination this appeared to be like that of a dog that had been savaged and the area around the eye in fact looked like a wound rather than a self inflicted injury.

Treatment

Considering that the initial appearance of the skin resembled that of a traumatic wound, it was decided to treat the presenting signs rather than any underlying condition as no underlying cause could be determined.

Vet Cream (Core A and Core B in the form of a cream) was administered. Sulphur

9x (Sulphur at a dilution 1 :10 ^'9 ) homeopathic was also supplied to be used on a twice daily basis just in case the owners assumption of a parasite cause such as sarcoptic

- 7 -

mange was correct and to provide a non steroid anti-puritic effect. However, this was stopped after confirmation from the owner that the wounds were the result of a fight, and administration twice daily of the Vet Cream was continued.

Results

The area below the eye with the open wound had completely disappeared in the intervening five weeks, with no trace of an open area. No trace of any wound was visible on the dorsal area.

EXAMPLE 13

Wound Healing Case Study - Treatment of a simple slow healing wound

Subject: Blonde coated Lurcher, Female Neutered, 14 months old

Conditions/Symptoms of Subject

The patient was presented three weeks after the initial injury with an incised-type wound that although small just would not heal.

Treatment

No antibiotic cover was provided during treatment, nor were any anti-inflammatories either topical or oral used during the treatment of this case. The only treatment used from the initial presentation to final cure was Vet Cream (Core A and B in the form of a cream) on a twice daily basis till the wound appeared to be healing and then to apply it once daily.

Within two days of starting the application of Vet Cream the wound had started to heal and the owner reduced application of the cream to once daily. Within six days the wound had healed completely.

EXAMPLE 14

Wound Healing Case Study

Subject: Greyhound Brindle & White Neutered Male 7 years old

Conditions/Symptoms of Subject

The injury was caused by running under a wooden pole and him catching his back on a protruding nut. The skin on the back literally peeled back.

Treatment & Results

The wound was repaired under general anaesthesia 0.1ml Acetylpromazine 2mg/ml IM as premed and Thiopentone 2.5% IV to effect (15ml used) as a knockdown dose and anaesthesia was maintained with Halothane. There was 90 minutes of surgical time excluding the time taken for preparation of the wound for surgical repair which included clipping the area and washing the skin margins with Hibiscrub surgical scrub followed by povodine iodine. The open wound was then bathed in sterile water with Homeopathic Mother tincture of Calendula (Marigold) at a dilution of 20 drops of mother tincture add to 100ml of sterile water. The wound was then sutured using mattress sutures to appose the edges, as the patient had a history of tearing wounds open. The large areas which were unattached to the underlying facial tissue were tacked down using single interrupted sutures to enhance the chances of reattachment. A decision was taken not to insert a drain into the wound initially. When wound repair was complete the patient was given a single 15 drop dose of Trauma/First Aide. Antibiotic cover was instigated with a single 2.5ml intramuscular injection of Synulox RTU (Pfizer). Maintenance of antibiotic cover was supplied by Synulox 250mg tablets (Pfizer) x15 at a dose rate of 1 ¹ /2 tablets twice daily.

Vet Cream (standard combination Core A and B in the form of a cream) was liberally applied to the entire affected area and the surrounding tissue close to the wound margin. The owner was instructed to apply the cream to the affected area 2-3 times daily. The patient had an uneventful recovery despite the degree of degloving and the extent of the wound and the previous history of the patient's wounds breaking down. The antibiotic cover was not extended beyond the initial 5 days and no analgesic or anti-inflammatory other than the Vet Cream was used. There was no

wound breakdown nor was there any need for a drain in the wound despite its extensive size, which is a common event with injuries such as this.

EXAMPLE 15

Severe Bruising (case with two fractured legs)

Subject - Labrador cross Retriever male 1 year old

Condition

Both hind legs were fractured as a result of a car impact. The damage done to the car indicated that the patient was lucky to be alive.

The endotracheal tube used to intubate the patient during anaesthesia was covered in blood indicating severe damage not just to the legs but also to the lungs with some degree of pneumothorax.

Treatment

The subject received three doses of Trauma/First Aid in the first twenty four hours, and then once daily for three days. The entire bruised area had a formulation of Vet Cream (Core A and Core B) applied on a daily basis for the first five days. The subject was also placed on Clindamycin 22mg/Kg twice daily for the initial 5 days but no anti-inflammatory or analgesic drugs were required.

By the end of the 5 day treatment period the subject was considered recovered to the point of being able to support weight on the legs. The subject also removed his sutures after less than twenty four hours following presentation, but as the wound remained closed this healed uneventfully despite the severe bruising of the immediate tissue. This case indicates that the Trauma/First Aid treatment promoted rapid healing, promoted extremely rapid resolution of the wounds, bruising and fractures. What is unexpected for an injury such as this is the speed of recovery and the disappearance of all bruising in less than 6 days such that the subject was able to put weight on both back legs.

- -

EXAMPLE 16

Use of Anti-Infective Core A for paw that was golf ball sized due to bite abscess.

Subject: Cat 3 years

Condition: Injured paw with bite abscess

Treatment Core A at a low C potency was administered to the subject in liquid form for oral mucosal administration.

The above homeopathic complex was supplied in a base of 20% alcohol and 80% water, as well as second base of 30% glycerine and 70% purified water. Both were administered to the same patient to assess if any difference in efficacy could be noted and both worked equally well.

The paw on Day 1 is shown in Figure 11a and 11b.

At day 10 the subject was putting equal weight on both feet.

EXAMPLE 17

Use of Anti-Infective Core A

Subject & Condition: Canine presented with anal gland abscess. Fig 12a shows, on Day 1 , an Anal Gland Abscess (arrowed) in the Left anal gland where the whole L side of the peri-anal area was extremely swollen and a sinus was discharging pus

Treatment The pus was cleaned away from the sinus and the midline and showed how much the area was swollen. The patient was given Core A only in high potency, above 200c, for oral administration.

The above homeopathic complex was supplied in a base of 20% alcohol and 80% water, as well as second base of 30% glycerine and 70% purified water. Both were administered to the same patient to assess if any difference in efficacy could be noted and both worked equally well.

No other form of medication (including antibioitics) was used.

On Day 3, the wound was no longer discharging pus and the swelling in the area was vastly reduced.

As the abscess had cleared, a Vet Cream (comprising Core A and Core B in the form of a cream) formulation was applied to the affected area to enhance the healing. Fig 12b shows the anal gland abscess on Day 7 which had completely cleared and the sinus was completely closed. 4 days after administration of Vet Cream complete

_

resolution of the wound had occurred. Both the speed of abscess and wound resolution in this case were remarkable.

EXAMPLE 18

Subject & Condition

A surface tissue injury to the left thumb of a human subject caused by the trapping of the thumb between a power hose and a granite stone.

Treatment

The injury was treated with Vet Cream (Core A and Core B in a cream) which was liberally applied to the entire affected area and the tissue immediately surrounding the wound margin.

Within 24 hours following treatment with Vet Cream Formulation the left thumb showed a significant degree of healing allowing the subject to continue to work manually with dirt and water and no protective covering on the wound. Despite regular immersion in water during the subject's work day, the wound healed further (data not shown).

Two days from the initial injury and after a full day's work again, which includes manual labour and immersion in water while being unprotected, it was observed that further rapid healing had occurred despite it being on a point of flexion where healing is usually much slower.

Less than one month after the original injury (Day 27), the wound was entirely healed despite continuous manual work and daily immersion in water.

This example demonstrates how effective the Vet Cream Formulation is in treating human injuries as well as animals under even more rigorous conditions than would normally be expected, as the wound was on a flexing region and was immersed daily in water and subjected to hard manual work.

_ _

EXAMPLE 19

Subject & Condition

The subject presented with severe bruising and pain around the ankle joint and foot immediately after a hamstring injury.

Treatment

Trauma/First Aid treatment was taken three times in the 8 hours post injury and Vet Cream (Core A and Core B in a cream formulation) was applied to the area of the injury and the area of subsequent bruising.

The cream was applied twice daily for 3 days in morning and evening and then daily for 3 days. After that the cream was applied approximately every 2 ^nd day twice daily.

A similar injury had occurred to the opposite leg a few years previously which took in excess of 6 weeks to recover and walk without a leg stocking to keep down the oedema, swelling, and bruising. In this case where the subject was treated with the Trauma/First Aid treatment and Vet Cream Formulae, the subject was walking reasonably comfortably by the 7 ^th day post injury, and by the 15 ^th day post injury the subject was back cycling despite the fact that the initial assessment of the injury was much worse.

EXAMPLE 20 Wound Healing Case Study - Treatment of a septic compound fracture and accompanying wound.

Subject : Black and White Domestic Shorthaired Cat MN less than 1 year old

Conditions/Symptoms of Subject

The subject had been presented to two different veterinary surgeries. The first veterinary surgeon had given Betamox LA (suspension containing 150 mg/ml amoxycillin as Amoxycillin Trihydrate BP) at the correct dose of 15 mg per kg bodyweight and was given further antibiotic cover provided by a single long acting injection of Convenia at the correct dose of 8 mg cefovecin/kg body weight (1 ml/10

kg body weight of) by a second veterinarian surgeon. About 24 hours after returning to his carers the wound started to discharge pus again, but it was decided to wait as the patient was on Convenia and improvement might still occur. However, the wound continued to discharge purulent material.

Treatment

On initial presentation the affected region produced a profuse purulent discharge, which was foetid in odour, when pressed and the whole area felt like it might slough due to the purulent undermining. The femur could be felt under the skin and had obviously penetrated through the wound site, before slipping back in giving a compound fracture. The wound was flushed with Calendula & Echinacea Mother tincture diluted at a rate of 20 drops (1ml) per 100ml of Sterile water and 1ml of Antirobe (clindamycin hydrochloride) 100mg/ml. The subject was also injected with Antirobe (clindamycin hydrochloride) 100mg/ml at a dose rate of 22mg/Kg. A request was put in to the original veterinary practice for a full case history and x-rays, which are shown in Figs. 13c and 13d.

The condition of the leg following a 2 ^nd flushing with Calendula Echinacea and Clindamycin solution was improved, with the discharge being less purulent. However, some small clots of pus and necrotic debris could still be seen in the serous discharge that still came profusely from the wound.

A decision to surgically repair the leg, if possible, was taken. Fig 13f shows that some of the muscle shearing caused by the distal portion of the femur which perforated the skin had become septic.

Pre-surgery the subject was put on a daily injection of Antirobe (clindamycin hydrochloride) 10Omg/ml at a dose rate of 22mg/Kg. The subject was anaesthetised using xylazine and ketamine as knock down agents and maintained in isoflourane. A decision to try and repair the leg was taken at this point and surgical intervention was under taken to attempt a full reduction of the fracture site. When the lower portion of the femur was exteriorised both veterinarians involved in the surgery were absolutely taken aback by the absolutely foetid odour of the distal femur, particularly the bone marrow. A decision was taken remove as much bone marrow as possible and then to wash out the cavity with a homeopathic complex consisting of Echinacea, Hepar

Sulph, Calendula, Symphytum and Gunpowder in various potencies, chosen on the basis of the foetid odour and the osteomyelitis. 500Dl of Clindamycin 100mg/ml was also introduced into the cavity. An intramedullary pin of a size smaller than would normally be used was introduced into the upper fragment of the femur and then into the lower portion of the femur resulting in a complete reduction of the fracture. Crystapen as a white soluble dry sterile powder, containing 95.7% w/w Sodium Benzylpenicillin BP, for reconstitution (with Water for Injection Ph. Eur), in bottles containing 5 mega-units (3 g) at a dose of rate of 10mg/Kg and Antirobe (clindamycin hydrochloride) 100mg/ml at a dose rate of 22mg/Kg. were introduced directly around the fracture site. The wound was then closed with simple interrupted cat gut sutures for the internal layers and the skin wound was sutured using polyamide sutures.

Fig, 13a and Rg. 13c shows the post surgical wound site with Vet Cream applied and it shows the sinus tract to the infected bone. Immediately post surgery 10 drops of Trauma/First Aid treatment was given.

Post surgical care involved cage rest for 26 days. Initially twice daily applications of Vet Cream were done, a 10 day course of Clindamycin 100mg/ml at a dose rate of 22mg/Kg IM, a 5 day course of Silica 200c homeopathic in liquid Solution was administered at a dose rate of 5 drops twice daily. Subsequent to stopping the treatment, the subject was started on CaIc Phos homeopathies in high potency daily for 3 days to improve bone healing and Symphytum in low potency was administered twice daily at a different time of day for 10 days. Both were administered away from food. *

Twenty four hours after surgery the patient's wound was already healing well and the sinus had actually closed. Probiotics and Prebiotics were given for the first 10 days and neither anti-inflammatories nor were analgesics administered. The subject was attempting to walk from the next day, which is a common result where Trauma/First Aid has been used with Vet Cream.

Just two days after surgery, the subject was standing unsupported on the injured leg and the large open wound is already starting to heal. Also, it was noticed that with Vet Cream treatment, hair re-growth is enhanced as well as wound repair.

. .

As the subject developed a liking to the taste of the Vet Cream, it was necessary to simply apply the Vet Cream just as the subject was being fed. In addition, the subject was still being given Clindamycin daily, probiotics, Vet Cream a course of Silica 200c at this point.

Fig. 13b demonstrates that merely 11 days post surgery, the subject's wound has dramatically healed. What is also of note is the level of hair re-growth as can be seen when compared to Fig. 13a.

At this point it was decided to temporarily stop applying the Vet Cream and allow the wound to heal as it was doing. What was remarkable was that little healing took place over the next 10 days. As such, Vet Cream was reapplied daily for a couple of days which once again promoted not just rapid healing but further hair growth prior to the subject's discharge.

CONCLUSION

Both veterinarians and the nurse involved had not expected this case to resolve following surgical intervention based on the incredibly foul sepsis at the time of the surgery. Apart from all the other factors mitigating against recovery, the initial lack of response to antibiotic cover and the introduction of a foreign substance in the form of an intramedullary pin into such septic circumstances would normally further add to the difficulty in having any success in clearing up the sepsis. The results obtained were completely unprecedented.

Furthermore, in a large number of cases enhanced tissue regeneration has been seen with hair regrowth. Such enhanced tissue regeneration appears to extend to septic bone healing in this case. The patient returned to normal function extremely rapidly demonstrating an analgesic effect, a tissue restoration effect covering hair skin, muscle, connective, and bone tissue while at the same time enhancing organ function recovery.