TITLE OF THE INVENTION

Veterinary herbal compositions and medicaments thereof.

This application claims priority from Indian Patent Application No. 1033/CHE/2011 filed on 31 ^st March 2011.

FIELD OF THE INVENTION:

The present invention relates to veterinary herbal compositions and medicaments thereof.

Particularly, the invention relates to the veterinary herbal compositions and medicaments thereof; for treatment of ephemeral fever.

BACKGROUND AND PRIOR ART:

An ephemerovirus infection of cattle is caused by bovine ephemeral fever virus of the family Rhabdoviridae. Bovine ephemeral fever is an acute, arthropod-borne disease of cattle. The disease is characterized by sudden onset of fever, stiffness and disinclination to movement accompanied by lameness, high morbidity and very low mortality. Recovery usually occurs within three to four days of the onset of clinical signs. Although mortality is usually low, cattle in good condition are usually affected more severely; mortality rates can be higher than 30% in very fat cattle.

Bovine ephemeral fever (BEF) is a viral disease of cattle and buffaloes besides subclinical involvement of a variety of ruminant species. The clinical severity of the disease is not apparent and the mortality is low. However, it can cause significant economic impact through reduced milk production in dairy herds, loss of condition in beef cattle, loss of draught animals at the time of harvest, abortion, temporary infertility in bulls, and prolonged recovery in some animals as well as trade restrictions. Available evidence indicates clinical signs of BEF, which include biphasic fever, anorexia, muscle stiffness, ocular and nasal discharge, ruminal statis and recumbency, are due primarily to a vascular inflammatory response. Recovery usually occurs within three to four days, hence the term ephemeral. The causative virus is transmitted by haematophagous insects that appear to be borne on the wind, allowing rapid spread of the disease. LS/NIF/03 2

The vector for bovine ephemeral fever is not proven, but the disease appears to be spread mainly by mosquitoes. Ephemeral fever virus has been isolated from Culex and Anopheles mosquitoes in Australia, and from Culicoides biting midges in Africa and Australia. The timing of outbreaks supports mosquitoes as a vector. The disease can also be spread by intravenous inoculation of small amounts of blood. Bovine ephemeral fever is not transmitted by close contact, bodily secretions, or aerosol droplets. The virus does not seem to be transmitted in semen and is rapidly inactivated in meat. Carriers are not known to occur. The prevalence, geographic range, and severity of the disease vary from year to year, and epidemics occur periodically. During epidemics, onset is rapid; many animals are affected within days or 2-3 wk. Ephemeral fever is most prevalent in the wet season in the tropics and in summer to early autumn in the subtropics or temperate regions (when conditions favor multiplication of biting insects); it disappears abruptly in winter. Morbidity may be as high as 80%; overall mortality is usually 1-2%, although it can be higher in lactating cows, bulls in good condition, and fat steers (10-30%).

Ephemeral fever is one of the rare virus diseases for which treatment is effective. The inflammatory nature of the disease process means it is responsive to anti-inflammatory drugs. These drugs must be given for the expected course of the clinical disease. Also, relapses occur in ephemeral fever if anti-inflammatory treatment is discontinued too early.

Chinese Patent publication no CN 101829285 discloses Chinese medicine for treating bovine ephemeral fever and the application method thereof. The medicament formula comprises of honeysuckle flowers, houttuynia cordata, bamboo leaves, common andrographis herbs, gardenia, Chinese rhubarb powder, licorice powder.

There's a boost in modern allopathic medicine with advancement in science and technology. Many new and more potent antibiotics have been discovered. Many wonder drugs have come up. But unfortunately these drugs are not free from adverse reactions and very often they are not safe for prolonged use. Sometimes the efficacy of certain drugs either falls to zero or becomes doubtful due to some undesirable reactions which are often irreversible. On the other hand, the efficacy of herbal medicine goes without any doubt and their healing effects are sustainable. Unlike modern allopathic medicines, traditional herbal medicines do not have LS/NIF/03 3 adverse or side effects and are completely safe. Hence, herbal medicines are well accepted and work with synergism in human body to fight out the diseases causing factors or elements.

Herbal medicines are the most affordable treatment that poor people from remote places can have access to. This is the main reason why herbal drugs are widely used in primary healthcare in treating the rural populations. In this scenario, Herbal drugs can play a meaningful role in the treatment of a number of diseases.New solutions are becoming the need of the hour for treatment of Filariasis.

Research has been always carried out with new medicaments, which can efficiently cure ephemeral fever.

We have carried out the prior art search and have not come across single document which shows/ teaches / demonstrates the composition comprising Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelos.

OBJECTS OF THE INVENTION:

An object of the invention is to provide veterinary herbal composition and medicament thereof for treatment of ephemeral fever.

Another object of the invention is to provide veterinary herbal composition and medicament thereof for treatment of ephemeral fever; said composition and medicament comprising Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelo.

Yet another object of the invention is to provide veterinary herbal composition and medicament thereof for treatment of ephemeral fever; said medicament may be administered orally or topically or injected intravenously, subcutaneously, etc or by any other suitable route of administration.

Still another object of the invention is to provide veterinary herbal composition and medicament thereof for treatment of ephemeral fever; wherein said composition and medicament is efficient and economic. LS/NIF/03 4

An additional object of the invention is to provide veterinary herbal composition and medicament thereof for treatment of ephemeral fever; wherein said composition and medicament shows enhanced efficacy.

Another additional object of the invention is to provide veterinary herbal composition and medicament thereof for treatment of ephemeral fever; wherein said composition and medicament shows high safety to host substantially without side effects.

Yet another additional object of the invention is to provide method of treatment for ephemeral fever by using the said herbal composition and medicament thereof which is more efficient and helps to eradicate the diseases substantially.

DETAILED DESCRIPTION OF THE INVENTION:

The present invention as described below, it is to be understood that this invention is not limited to particular methodologies and materials described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only, and is not intended to limit the scope of the present invention.

Before the present invention is described, it is to be understood that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Further, it is to be understood that the present invention is not limited to the methodologies and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described, as these may vary within the specification indicated. Unless stated to the contrary, any use of the words such as "including," "containing," "comprising," "having" and the like, means "including without limitation" and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it. Embodiments of the invention are not mutually exclusive, but may be implemented in various combinations. The described embodiments of the invention and the disclosed examples are given for the purpose of illustration rather than limitation of the invention as set forth the appended claims. Further the terms disclosed LS/NIF/03 5

^• embodiments are merely exemplary methods of the invention, which may be embodied in various forms.

It is also to be understood that the terms "a", "an", "the" and like are words for the sake of convenience and are not to be construed as limiting terms. Moreover, it will be understood that the illustrations are for the purpose of describing a particular exemplary embodiment of the invention and are not limited to the invention thereto.

It is also understood that the terms "sieving", "washing", grinding", "drying", "extraction" used herein intend to cover all kinds of conventional methods used for the said purpose carried out at room temperature unless specified particularly herein.

The herbal composition and medicament thereof of the present invention is simple, natural, attractive and convenient to use. The manufacture method for herbal medicine is simple and the effect is excellent; the price is low. The herbal composition and medicament thereof is useful in the treatment of the field of veterinary.

To achieve our object of the invention, we have studied the combination of Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck or Aegle marmelos in different proportions and their effect for treating ephemeral fever.

Acalypha indica (Tamil: Kuppaimeni) is a species of plant. It occurs throughout tropical Africa and South Africa, in India and Sri Lanka, as well as in Yemen and Pakistan. It has possibly been introduced elsewhere as a weed. In West and East Africa the plant is used as a medicinal plant. In West Africa the leaves are cooked and eaten as a vegetable. It is also browsed by cattle. This plant is held in high esteem in traditional Tamil Siddha medicine as it is believed to rejuvenate the body.

Azima tetracantha belonging to the family Salvadoraccae is Spiny scrambling shrub. Azima tetracantha occurs naturally in central, eastern and southern Africa as well as in the Indian Ocean islands, and extends through Arabia to tropical Asia. Azima tetracantha appears to be limited and only occasional in Africa. The fruit is edible. Azima tetracantha is browsed by livestock. It is planted as live fence in Bangalore (India). In Malaysia pickled leaves are used as an appetizer and against colds. As all parts containing glucosinolates, further research on LS/NIF/03 6 medicinal applications is warranted. The plant is promoted as an ornamental in the United States.

Brassica juncea also known as Mustard, Leaf mustard, Indian mustard, Sarson belongs to the family Brassicaceae. There are two varieties of mustard seeds; one is black mustard and the other is white mustard, which are used for medicinal purpose as well as food, since centuries. Ayurvedic Samhita has vividly described the properties and medicinal uses of these two varieties separately. Though they are two separate herbs, more or less, their properties are similar. Charaka has categorized the white variety as asthapanopaga ie adjunct to decoction enemas and the black variety as kandughna ie antipruritic. The plant is cultivated throughout India, especially in Bihar, Bengal and Uttar Pradesh. It is a large branching annual, growing up to 0.6-1 meter in height. The leaves are broadly ovate, coarsely dentate, the lowest ones lyrate and slightly hispid whereas, the upper ones lanceolate, all stalked, dark green in colour. The flowers are in corymbose racemes, stalked, bright yellow. The seeds are brownish-red, tiny.

The genus Albizzia comprises approximately 150 species, mostly trees and shrubs native to tropical and subtropical regions of Asia and Africa (Allen and Allen 1981 , National Research Council 1979). Albizzia lebbeck is native to deciduous and semi deciduous forests in Asia from eastern Pakistan through India and Sri Lanka to Burma. The tree has been introduced as an ornamental and plantation tree throughout the tropics and northern subtropics, including the Greater and Lesser Antilles, Central America, Colombia, Venezuela, and Brazil (Adams 1972, Grisebach 1864, Hutchinson and Dalziel 1958, Little and Wadsworth 1964). Albizzia lebbeck is a fast-growing, medium-sized deciduous tree with a spreading umbrella-shaped crown of thin foliage and smoothish, finely fissured, grayish-brown bark.

Bael (Aegle marmelos) belongs to Rutaceae family. The bael is a large tree, 8 to 10 meters in height. It has a big stout trunk, unusual branches with long, straight outgrowth, aromatic leaves, and sweet scented and greenish-white flowers. The fruit is woody and smooth, 5 to 15 cm in diameter. It has numerous seeds which are densely covered with fibrous hair and are embedded in a thick aromatic pulp. The flesh is eaten fresh or dried. Bael tree is held sacred by the Hindus. The history of this tree has been traced to Vedic period (2000 B.C. 800 B.C.). The mention of bael fruit has been made in Yajurveda. The bael tree has great mythological LS/NIF/03 7 significance and abounds in the vicinity of temples. The bael tree is indigenous to India and is grown throughout the sub-continent as well as most countries of South-east Asia.

The scope of the present invention comprises use of different parts of Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelos to prepare the composition and medicament comprising the same.

According to one of the embodiments of the invention, there is provided herbal composition for treatment of ephemeral fever;

said composition comprising predefined amount of Acalypha indica; predefined amount of Azima tetracantha; predefined amount of Brassica juncea; predefined amount of Albizzia lebbeck and predefined amount of Aegle marmelos.

Preferably, the said herbal composition comprising 70% to 80% of Acalypha indica, 10%) to 20%) of Azima tetracantha, 1% to 5% of Brassica (juncea, 10% to 15% Albizzia lebbeck and 1% to 5% of Aegle marmelos. All percentages are percent by weight of the mixture.

Particularly, leaves of Acalypha indica are used in the herbal composition of the invention.

Particularly, 70%> to 80%> of the leaves of Acalypha indica are used in the herbal composition of the invention.

Particularly, leaves of Azima tetracantha are used in the herbal composition of the invention.

Particularly, 10% to 20%> of the leaves of Azima tetracantha are used in the herbal composition of the invention.

Particularly, leaves of Brassica juncea are used in the herbal composition of the invention.

Particularly, 1%> to 5% of the leaves of Brassica juncea are used in the herbal composition of the invention.

Particularly, leaves of Albizzia lebbeck are used in the herbal composition of the invention. LS NIF/03 8

Particularly, 10% to 15% of the leaves of Albizzia lebbeck are used in the herbal composition of the invention.

Particularly, leaves of Aegle marmelos are used in the herbal composition of the invention.

Particularly, 1% to 5% of the leaves of Aegle marmelos are used in the herbal composition of the invention.

Presently we have used leaves of Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelos. However, use of other parts of Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelos in the composition should be considered within the scope of the invention.

The said herbal composition is used in the treatment of ephemeral fever. The composition is found to be efficient and showed enhanced efficacy against ephemeral fever in animals.

According to yet another embodiment of the invention there is provided a method for the preparation of said herbal composition for the treatment of ephemeral fever;

said method comprises;

a. sieving followed by washing and sieving again predefined amount of leaves of Acalypha indica followed by drying and making paste or juice by conventional means; b. sieving followed by washing and sieving again predefined amount of leaves of Azima tetracantha followed by drying and making paste or juice by conventional means;

c. sieving followed by washing and sieving again predefined amount of leavesof Brassica juncea followed by drying and making paste or juice by conventional means;

d. sieving followed by washing and sieving again predefined amount of leaves of Albizzia lebbeck followed by drying and making paste or juice by conventional means;

e. sieving followed by washing and sieving again predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice by conventional means; and f. mixing all pastes or juices obtained in steps (a), (b), (c), (d) and (e) together to obtain synergistic composition. LS/NIF/03 9 The method optionally comprises:

g. sieving followed by washing and sieving again predefined amount of leaves of Acalypha indica, predefined amount of leaves of Azima tetracantha, predefined amount of leaves of Brassica juncea, predefined amount of leaves of Albizzia lebbeck and predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice of them together by conventional means to obtain synergistic composition.

Instead of paste or juice of leaves of Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelos; the composition may comprises the extract like a whole plant extract, a rhizome extract, a leaf extract, a seed extract, a root extract, a bark extract, a flower extract, a fruit extract, and a combination thereof.

The extract is generally prepared in a solvent, typically water, alcohol or combination thereof. However, other solvents and solutions compatible with plant usage and habitat may also be used.

A mixture of water and alcohol used for extraction is in the proportion of 60:40. The 50 ml of either water or alcohol or the mixture of water and alcohol is used for the extraction.

The extraction can be carried out in a temperature controlled extraction vessel at a temperature between 50°C to 70°C. Preferably, the extraction can be carried out at controlled temperature between 55°C to 65°C.

According to still another embodiment of the invention, there is provided a method for the preparation of said composition for treatment of ephemeral fever;

said method comprising :

h. sieving followed by washing and sieving again predefined amount of leaves of Azima tetracantha followed by drying and making paste or juice by conventional means and extracting the paste or juice obtained with solvent at controlled temperature between 50°C to 70°C;

i. sieving followed by washing and sieving again predefined amount of leaves of Azima tetracantha followed by drying and making paste or juice by conventional means and LS/NIF/03 10 extracting the paste or juice obtained with solvent at controlled temperature between 50°C to 70°C;

j. sieving followed by washing and sieving again predefined amount of leaves oiBrassica juncea followed by drying and making paste or juice by conventional means and extracting the paste or juice obtained with solvent at controlled temperature between 50°C to 70°C;

k. sieving followed by washing and sieving again predefined amount of leaves of Albizzia lebbeck followed by drying and making paste or juice by conventional means and extracting the paste or juice obtained with solvent at controlled temperature between 50°C to 70°C;

1. sieving followed by washing and sieving again predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice by conventional means and extracting the paste or juice obtained with solvent at controlled temperature between 50°C to 70°C; and

m. mixing all extracts obtained in steps (h), (i), (j), (k) and (1) together to obtain synergistic composition .

The method optionally comprises:

n. sieving followed by washing and sieving again predefined amount of leaves of Acalypha indica, predefined amount of leaves oiAzima tetracantha, predefined amount of leaves of Brassica juncea, predefined amount of leaves of Albizzia lebbeck and predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice of them together by conventional means to obtain synergistic composition; and o. extracting the composition obtained in step (n) with solvent at controlled temperature between 50°C to 70°C at controlled temperature between 50°C to 70°C.

The extraction steps (h), (i), (j), (k), (1) and (o) are carried out in a temperature controlled extraction vessel. Preferably, the steps (h), (i), (j), (k), (1) and (o) are carried out at controlled temperature between 55°C to 65°C.

The solvent used for the extraction is water, alcohol like ethanol or methanol or combination thereof. However, other solvents and solutions compatible with plant usage and habitat may also be used. A mixture of water and alcohol used for extraction is in the proportion of 60:40. LS/NIF/03 11

The 50 ml of either water or alcohol or the mixture of water and alcohol is used for the extraction.

The extracts obtained in step (m) and (o) is converted into semi solid or solid dosage form by conventional means which includes but is not limited to using vacuum rotary evaporator, lyophilization or the like.

Particularly, the processing of Acalypha indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelos is carried out either together or separately.

Preferably, all ingredients are thoroughly washed and sieved prior to making paste and extraction.

To prepare the composition of the present invention, the components are first thoroughly washed and dried well. Thereafter they are sieved to remove remaining impurities and preferably, washed again with sterile water.

The composition of the present invention based on the above herbs acts as a synergistic composition having unexpected and new properties in the treatment of ephemeral fever. The combination of above-mentioned components in the treatment of ephemeral fever is therefore, truly inventive and non obvious.

According to yet another embodiment of the invention, there is provided herbal medicament for the treatment of ephemeral fever;

said medicament comprising predefined amount of composition of the invention along with either suitable pharmaceutically acceptable excipient, vehicle and / or adjuvant suitable for administering orally or topically or injectable including intravenous, subcutaneous, etc or intramuscular, by any other suitable route of administration.

Preferably, the said herbal medicament comprising 70% to 80% of Acalypha indica, 10% to 20% of Azima tetracantha, 1% to 5% of Brassica juncea, 10% to 15% Albizzia lebbeck and 1% to 5% of Aegle marmelos. All percentages are percent by weight of the mixture. LS/NIF/03 12

The said herbal medicaments are used in the treatment of ephemeral fever and found to be efficient and with enhanced efficacy against ephemeral fever in both human and animals.

According to still yet another embodiment of the invention there is provided method for the preparation of said herbal medicaments for treatment of ephemeral fever;

said method comprises:

i. sieving followed by washing and sieving again predefined amount of leaves of Acalypha indica followed by drying and making paste or juice by conventional means; ii. Sieving followed by washing and sieving again predefined amount of leaves of Azima tetracantha followed by drying and making paste or juice by conventional means; iii. sieving followed by washing and sieving again predefined amount of leaves of Brassica juncea followed by drying and making paste or juice by conventional means;

iv. sieving followed by washing and sieving again predefined amount of leaves of Albizzia lebbeck followed by drying and making paste or juice by conventional means;

v. sieving followed by washing and sieving again predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice by conventional means;

vi. mixing all paste or juice obtained in steps (i), (ii), (iii), (iv) and (v) together to obtain synergistic composition;

vii. optionally adding either suitable excipient, vehicle or adjuvant to the composition obtained in step (vi); and

viii. converting the composition obtained in step (vi) or (vii) into medicament by conventional method;

said medicament for administering orally or topically or injectable including intravenous, subcutaneous, etc or by any other suitable route of administration.

The method optionally comprises :

ix. sieving followed by washing and sieving again predefined amount of leaves of Acalypha indica, predefined amount of leaves of Azima tetracantha, predefined amount of leaves of Brassica juncea, predefined amount of leaves of Albizzia lebbeck, and predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice of them by conventional means to obtain synergistic composition;

x. optionally adding either suitable excipient, vehicle or adjuvant to the composition obtained in step (ix); and LS/NIF/03 13 xi. converting the composition obtained in step (ix) or (x) into medicament by conventional method;

said medicament for administering orally or topically or injectable including intravenous, subcutaneous, etc or by any other suitable route of administration.

Preferably, the said herbal medicament comprising 70% to 80%> of Acalypha indica, 10%> to 20% oiAzima tetracantha, 1%> to 5%> of Brassica juncea, 10%> to 15%> Albizzia lebbeck and 1%> to 5% of Aegle marmelos. All percentages are percent by weight of the mixture.

The method optionally comprises :

xii. sieving followed by washing and sieving again predefined amount of leaves of Acalypha indica followed by drying and making paste or juice by conventional means and extracting the paste or juice so obtained with solvent at controlled temperature between 50°C to 70 °C;

xiii. sieving followed by washing and sieving again predefined amount of leaves of Azima tetracantha followed by drying and making paste or juice by conventional means and extracting the paste or juice so obtained with solvent at controlled temperature between 50°C to 70 °C;

xiv. sieving followed by washing and sieving again predefined amount of leaves of Brassica juncea followed by drying and making paste or juice by conventional means and extracting the paste or juice so obtained with solvent at controlled temperature between 50°C to 70 °C;

xv. sieving followed by washing and sieving again predefined amount of leaves of Albizzia lebbeck followed by drying and making paste or juice by conventional means and extracting the paste or juice so obtained with solvent at controlled temperature between 50°C to 70 °C;

xvi. sieving followed by washing and sieving again predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice by conventional means and extracting the paste or juice so obtained with solvent at controlled temperature between 50°C to 70 °C;

xvii. mixing all extracts obtained in steps (xii), (xiii), (xiv), (xv) and (xvi) together to obtain synergistic composition; LS/NIF/03 14 xviii. optionally adding either suitable excipient, vehicle or adjuvant to the composition obtained in step (xvii);

xix. converting the composition obtained in step ^' (xvii) or (xviii) into medicament by conventional method;

said medicament for administering orally or topically or injectable including intravenous, subcutaneous, etc or by any other suitable route of administration.

The method optionally comprises :

xx. sieving followed by washing and sieving again predefined amount of leaves of Acalypha indica, predefined amount of leaves of Azima tetracantha, predefined amount of leaves of Brassica juncea, predefined amount of leaves of Albizzia lebbeck, and predefined amount of leaves of Aegle marmelos followed by drying and making paste or juice of them by conventional means to obtain synergistic composition;

xxi. extracting the paste or juice obtained in step (xx) with solvent at controlled temperature between 50°C to 70 °C followed by converting the extract into semi solid or solid form to obtain synergistic composition;

xxii. optionally adding either suitable excipient, vehicle or adjuvant to the composition obtained in step (xxi);

xxiii. converting the composition obtained in step (xxi) or (xxii) into medicament by conventional method;

said medicament for administering orally or topically or injectable including intravenous, subcutaneous, etc or by any other suitable route of administration.

Preferably, the said herbal medicament comprising 70% to 80% of Acalypha indica, 10%) to 20% of Azima tetracantha, l% to 5% of Brassica juncea, 10%) to 15% Albizzia lebbeck and 1%> to 5% of Aegle marmelos. All percentages are percent by weight of the mixture.

The extraction steps (xii), (xiii), (xiv), (xv), (xvi) and (xx) are carried out in a temperature controlled extraction vessel. Preferably, the steps (xii), (xiii), (xiv), (xv), (xvi) and (xx) are carried out at controlled temperature between 55°C to 65°C.

The solvent used for extraction in step (xii), (xiii), (xiv), (xv), (xvi) and (xx) is alcohol like methanol, ethanol, water or mixture thereof. 50 ml of either water or alcohol or the mixture of LS/NIF/03 15 water and alcohol is used for the extraction. A mixture of water and alcohol used for extraction is in the proportion of 60:40.

The extracts so obtained as above can be converted into semi solid or solid form composition by conventional method like rotary evaporation, lyophilization, etc.

In still another embodiment of the invention, the said medicament can be administered orally or topically or injected intravenously, subcutaneously, etc or by any other suitable route of administration.

In oral administration, the herbal medicament may be in the form including but not limited to tinctures, herbal wine, elixirs, tisanes, decoctions, powder, juice, syrup, tablets, granules, capsules, etc.

In topical administration, the herbal medicament may be in the form including but not limited to oils, salves, balms, cream, lotion, spray, poultices, compresses, etc.

In administration by injection, the herbal medicament may be in the form including but not limited to bolus, intravenous injection, subcutaneous injection, intramuscular injection, intrathecal, etc.

Particularly, Tinctures are alcoholic extracts of herbs; usually obtained by combining 100% pure ethanol (or a mixture of 100% ethanol with water) with the herb. A completed tincture has ethanol percentage of at least 25% (sometimes up to 90%). The term tincture is sometimes applied to preparations using other solvents than ethanol.

Herbal wine and elixirs are alcoholic extract of herbs; usually with an ethanol percentage of 12-38%. Herbal wine is a maceration of herbs in wine, while an elixir is a maceration of herbs in spirits (e.g., vodka, grappa, etc.).

Tisanes are hot water extracts of herb.

Decoctions are long-term boiled extract of herb. LS/NIF/03 16

Powder and Juices: In this whole herb is consumed either in dried form (herbal powder), or fresh juice, (fresh leaves and other plant parts).

Syrups - Extracts of herbs made with syrup or honey. Sixty five parts of sugar are mixed with 35 parts of water and herb. The whole is then boiled and macerated for three weeks.

Salves, oils, balms, creams and lotions: Most topical applications are oil extractions of herbs. Taking a food grade oil and soaking herbs in it for anywhere from weeks to months allows certain photochemicals to be extracted into the oil. This oil can then be made into salves, creams, lotions, or simply used as oil for topical application.

Poultices and compresses: The whole herb (or the appropriate part of the plant) usually crushed or dried and re-hydrated with a small amount of water and then applied directly in a bandage, cloth or just as is.

A fresh herb paste can be applied at affected site.

Injectable form: It can also be prepared in the injectable form

Bolus is a large time-release tablet that stays in the rumen of cattle, goats and sheep, etc. bolus can be administered intravenous injection, subcutaneous injection, intramuscular injection, intrathecal, etc.

According to another embodiment of the invention, there is provided a method of treatment of ephemeral fever;

said treatment comprises administration of said herbal medicament of the invention either orally or topically or injectable including intravenous, subcutaneous, etc or by any other suitable route of administration.

The medicaments may be continued for until the symptoms of the disease get cured.

The herbal composition and medicament thereof of the invention is found to be efficient for treatment of ephemeral fever. It was prepared from the herbs which are available at cheaper price, thereby making the composition and medicament economic. The composition and medicament found to enhance efficacy as compared to that of individual use of Acalypha LS/NIF/03 17 indica, Azima tetracantha, Brassica juncea, Albizzia lebbeck and Aegle marmelos. The composition was found to be substantially without side effects.

The present invention is illustrated by the following examples, which is not intended to limit the effective scope of the invention.

Example 1:

Preparation of the composition of the invention

Leaves of Acalypha indica (525gm), Azima tetracantha (75 gm), Brassica juncea (30 gm), Albizzia lebbeck (90 gm) and Aegle marmelos (30 gm) were sieved, washed and sieved followed by drying. All ingredients were grounded to get the homogeneous synergistic composition. The said composition was further converted into bolus by conventional means and was administered on crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250g per day for 3 days. It was observed that the crossbred cattle was cured in 3days.

Example 2:

Preparation of the composition of the invention

Leaves of Acalypha indica (525 gm), Azima tetracantha (75 gm), Brassica juncea (30 gm), Albizzia lebbeck (90 gm) and Aegle marmelos (30 gm) were sieved, washed and sieved followed by drying. All ingredients were grounded to get the homogeneous synergistic composition. The composition was extracted with 50 ml of mixture of water and alcohol in the ratio of 60: 40 at 60°C. The extract was further converted into bolus by conventional means and was administered on cross bred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250g per day for 2 days. It was observed that the crossbred cattle was relieved in 2 days.

Example 3:

Preparation of the composition of the invention

Leaves of Acalypha indica (525 gm), Azima tetracantha (75 gm), Brassica juncea (30 gm), Albizzia lebbeck (90gm) and Aegle marmelos (30 gm) were sieved, washed and sieved followed by drying separately. The leaves of Acalypha indica (525gm), Azima tetracantha (75gm), Brassica juncea (30 gm), Albizzia lebbeck (90 gm) and Aegle marmelos (30 gm) were LS/NIF/03 18 grounded separately to get individual pastes. The pastes so obtained was mixed and converted into bolus by conventional means. The bolus was administered on crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus 250g per day for 3 days.

It was observed that the crossbred cattle was relieved in 3 days.

Example 4:

Preparation of the composition of the invention

Leaves of Acalypha indica (525gm), Azima tetracantha (75 gm), Brassica juncea (30 gm), Albizzia lebbeck (90 gm) and Aegle marmelos (30 gm) were sieved, washed and sieved followed by drying separately. The leaves of Acalypha indica (525 gm), Azima tetracantha 75 gm), Brassica juncea 30 gm), Albizzia lebbeck (90 gm) and Aegle marmelos (30gm) were grounded separately to get individual pastes. The pastes so obtained were individually extracted with 50 ml mixture of water and alcohol in the ratio of 60: 40 at 60°C. All extracts were combined and converted into bolus by conventional means. The bolus was administered on crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus (250g) perday for 3 days. It was observed that the crossbred cattle was relieved in 3 days.

Example 5:

Comparative example

Leaves of Acalypha indica (525 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was further converted into bolus by conventional means and was administered on crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250gm per day for 5 days. It was observed that the crossbred cattle was relieved in 5 days.

Example 6:

Comparative example

Leaves of Acalypha indica (525 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was extracted with 50 ml mixture of water and alcohol in the ratio of 60: 40 at 60°C. The extract was further converted into bolus by conventional means and was administered on crossbed cattle infected with the ephemeral fever. The dosage given is 1 bolus 250 g per day for 4 days. It was observed that the crossbred cattle was relieved in 4 days. LS/NIF/03 19

Example 7:

Comparative example

Leaves of Azima tetracantha (75 gm) were sieved, washed and sieved followed bydrying. The leaves were grounded to get the smooth paste. The paste was further converted into bolus by conventional means and was administered on crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250g per day for 5. It was observed that the crossbred cattle was relieved in 5days.

Example 8:

Comparative example

Leaves of Azima tetracantha (75 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was extracted with 50 ml mixture of water and alcohol in the ratio of 60: 40 at 60°C. The extract was further converted into bolus by conventional means and was administered on crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250g per day for 5 days. It was observed that the crossbred cattle was relieved in 5 days.

Example 9:

Comparative example

Leaves of Brassica juncea (30 gm) were sieved^ washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was further converted into bolus by conventional means and was administered on Crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250g day for 4 days. It was observed that the Crossbred - was relieved in 4 days.

Example 10:

Comparative example

Leaves of Brassica juncea (30 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was extracted with 50 ml mixture of water and alcohol in the ratio of 60: 40 at 60°C. The extract was further converted into bolus by conventional means and was administered on Crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250 g per day for 6 days. It was observed that the Crossbred cattle was relieved in 6 days. LS/NIF/03 20

Example 11:

Comparative example

Leaves of Albizzia lebbeck (90 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was further converted into bolus by conventional means and was administered on Crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250gper day for 4 days. It was observed that the Crossbred cattle was relieved in 4 days.

Example 12:

Comparative example

Leaves of Albizzia lebbeck (90 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was extracted with 50 ml mixture of water and alcohol in the ratio of 60: 40 at 60°C. The extract was further converted into bolus by conventional means and was administered on Crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus of 250g day for 5 days. It was observed that the Crossbred cattle was relieved in 5 days.

Example 13:

Comparative example

Leaves of Aegle marmelos (30 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was further converted into bolus by conventional means and was administered on Crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus 250g per day for 6 days. It was observed that the Crossbred cattle was relieved in 6 days.

Example 14:

Comparative example

Leaves of Aegle marmelos (30 gm) were sieved, washed and sieved followed by drying. The leaves were grounded to get the smooth paste. The paste was extracted with 50 ml mixture of water and alcohol in the ratio of 60: 40 at 60°C. The extract was further converted into bolus by conventional means and was administered on Crossbred cattle infected with the ephemeral fever. The dosage given is 1 bolus 250g per day for 4 days. It was observed that the Crossbred cattle was relieved in 4 days. LS/NIF/03 ^' 21

It was found that herbal composition had effectively alleviated the ailment in comparison to individual constituents.

The present invention as described above, it is to be understood that this invention is not limited to particular methodologies and materials described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only, and is not intended to limit the scope of the present invention.