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Title:
WAKERI FOR WOUND HEALING
Document Type and Number:
WIPO Patent Application WO/2020/044368
Kind Code:
A1
Abstract:
This invention comprises Wakeri-fortified Kampillakadi Tailam/oil. The Wakeri fortification comprises oil extract of root bark powder of Wakeri being a component in the Kampillakadi oil. Kampillakadi oil being a medicinal oil comprising oil extract of Vavding, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya, Khadirsal, Dhayatiphul, Agaru, and Chandan added with Sarjaras. The invention comprises composition comprising Wakeri-fortified Kampillakadi oil for topical application; the compositions comprise (a) a tulle, (b) an ointment, (c) a liniment, (d) a capsule, (e) a wound healing spray, (f) a cream, and (g) a gel. A process of making Wakeri-fortified Kampillakadi oil is also provided.

Inventors:
GHARPURE MILIND OMKAR (IN)
GULGULE RAVINDRA RAMAKANT (IN)
Application Number:
PCT/IN2019/050619
Publication Date:
March 05, 2020
Filing Date:
August 27, 2019
Export Citation:
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Assignee:
GHARPURE MILIND OMKAR (IN)
GULGULE RAVINDRA RAMAKANT (IN)
International Classes:
A61K36/00
Other References:
SARVADE, DATTATRAY ET AL.: "THE QUEEN OF SPICES AND AYURVEDA: A BRIEF REVIEW", INT. J. RES. AYURVEDA PHARM., vol. 7, no. Suppl 4, 2 September 2016 (2016-09-02), pages 1 - 6, XP055697229
SAMAK, GEETHA ET AL.: "Inhibition of methicillin resistant Staphylococcus aureus by botanical extracts of Wagatea spicata", INT J PHARM PHARM SCI, vol. 4, no. 2, 26 April 2012 (2012-04-26), pages 533 - 535, XP055697232
DATABASE TKDL "Kampillakadi Taila", XP055697258, Database accession no. VK5/1082A
DATABASE TKDL 15 August 1973 (1973-08-15), "Pitikahara Yogah", XP055697264, Database accession no. RS17/2140A
DATABASE TKDL 15 August 1973 (1973-08-15), "Vakeri Lepa Yogah (Upadamse)", Database accession no. RS17/288B
Attorney, Agent or Firm:
SHETH, Girish Vijayanand (IN)
Download PDF:
Claims:
Claims:

1. A composition comprising Wakeri-fortified Kampillakadi Tailam/oil.

2. The composition comprising Wakeri-fortified Kampillakadi oil according to the claim 1; wherein:

a. Waken fortification comprises oil extract of root bark powder of Wakeri being a component in the Kampillakadi oil, i. Wakeri being a plant species identified by botanical latin name Wagatea spicata Dalzell)Wight synonym of Moullava spicata (Dalzell) Nicolson); and

b. Kampillakadi Tailam being a medicinal oil comprising oil extract of Vavding, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya, Khadirsal, Dhayatiphul, Agaru, and Chandan added with Sarjaras.

3. The composition comprising Wakeri-fortified Kampillakadi oil according to claim 2, wherein:

a. Vavding being a powder of seeds of Emblica ribes Burm.f, b. Kutaj being a powder of root bark and stem bark of Holarrhena antidysenterica (L.) Wall. Ex A. DC.,

c. Kapilla being trichomes/hair on the surface of fruits of Mallotus philippenis (Lam.) Muell. Arg., d. Trifala being a powder of seed coat of Emblica officinalis Gaertn, synonym Phyllanthus emblica Linn., Terminalia bellirica (Gaertn.) Roxb., Terminalia chebula Retz.,

e. Patolpatra being a powder of roots, fruit and leaves of Trichosanthes dioica Roxb.,

f. Bala being a powder of roots of Sida cordifolia L.,

g. Nimsal being a stem bark of Azadiracta indica A,Juss.,

h. Lodhra being a stem bark of Symplocos racemosa Roxb., i. Nagarmotha being a bulbous part of roots of Cyperus rotundus L., j . Charolya being a powder of seeds of Buchanania lanzan Spreng., k. Khadirsa being a stem bark Acacia catechu (L.H.) Willd., l. Dhayatiphul being a powder of flower of Woodfordia fruticosa (L.) Kurz,

m. Agaru being a powder of stem of Aquilaria agallocha (Lour.) Roxb.,

n. Chandan being a powder of fragrant core part of the stem of Santalum albam L.,

o. Sarjaras being a resin of Shorea robusta Roth.; and

p. Sesame oil being a oil of Sesamum indicum L,

4. The composition comprising Wakeri-fortified Kampillakadi oil according to claim 3 wherein the Wakeri-fortified Kampillakadi oil is an ingredient of a topical application composition.

5. The composition comprising Wakeri -fortified Kampillakadi oil comprises one or more composition selected from the group consisting of:

a. a tulle impregnated with Wakeri-fortified Kampillakadi oil.

b. an ointment with Wakeri-fortified Kampillakadi oil as at least one ingredient,

c. a liniment with Wakeri-fortified Kampillakadi oil as at least one ingredient,

d. a capsule filled with Wakeri-fortified Kampillakadi oil as at least one ingredient for topical application after pressing out of the oil e. a wound healing spray with Wakeri-fortified Kampillakadi oil as at least one ingredient,

f. a cream with Wakeri-fortified Kampillakadi oil as at least one ingredient, and

g. a gel with Wakeri-fortified Kampillakadi oil as at least one ingredient.

6. The composition comprising Wakeri-fortified Kampillakadi oil according to claim 5 wherein the Tulle comprises a sterile soft oil base made up of open weave woven cotton gauze, a smooth low-adherent non-adhesive wound dressing that allows the wound to drain its exudates.

7. A process of making Wakeri-fortified Kampillakadi oil comprising taking the ingredients in the weights provided below or a variation thereof keeping the relative proportions same, and following steps comprising: a. taking 150 gram each of Vavding powder, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya, Khadirsal, Dhayatiphul, Agaru, Chandan and Wakeri root bark powder, drying the same off and pulverizing the same to a powder, b. soaking the powder in 20 liter water for overnight,

c. adding sesame oil 12.50 kg, Sarjeras 510 gram and 60 liter water, d. boil down the mixture until all water evaporates,

e. wait overnight to settle down the mixture,

f. filter the mixture to obtain the medicated oil, and

g. 2.5 gram of Butyl athy dr oxytoluene (BHT),

AMENDED CLAIMS

received by the International Bureau on 10 February 2020 (10.02.2020)

Claims:

1. A composition comprising Wakeri-fortified Kampillakadi Tailam/oil.

2. The composition comprising Wakeri-fortified Kampillakadi oil according to the claim 1 ; wherein:

a. Wakeri fortification comprises oil extract of root bark powder of Wakeri being a component in the Kampillakadi oil, i. Wakeri being a plant species identified by botanical latin name Wagatea spicata Dalzell)Wight synonym of Moullava spicata (Dalzell) Nicolson); and

b. Kampillakadi Tailam being a medicinal oil comprising oil extract of Vavding, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya, Khadirsal, Dhayatiphul, Agaru, and Chandan added with Sarjaras.

3. The composition comprising Wakeri-fortified Kampillakadi oil according to claim 2, wherein:

a. Vavding being a powder of seeds of Emblica ribes Burm.f., b. Kutaj being a powder of root bark and stem bark of Holarrhena antidysenterica (L.) Wall. Ex A. DC.,

c. Kapilla being trichomes/hair on the surface of fruits of Mallotus philippenis (Lam.) Muell. Arg.,

d. Trifala being a powder of seed coat of Emblica officinalis Gaertn, synonym Phyllanthus emblica Linn., Terminalia bellirica (Gaertn.) Roxb., Terminalia chebula Retz., e. Patolpatra being a powder of roots, fruit and leaves of Trichosanthes dioica Roxb.,

f. Bala being a powder of roots of Sida cor difolia L.,

g. Nimsal being a stem bark of Azadiracta indica AJuss.,

h. Lodhra being a stem bark of Symplocos racemosa Roxb., i. Nagarmotha being a bulbous part of roots of Cyperus rotundus L., j. Charolya being a powder of seeds of Buchanania lanzan Spreng., k. Khadirsa being a stem bark Acacia catechu (L.H.) Willd., l. Dhayatiphul being a powder of flower of Woodfordia fruticosa (L.) Kurz,

m. Agaru being a powder of stem of Aquilaria agallocha (Lour.) Roxb.,

n. Chandan being a powder of fragrant core part of the stem of Santalum albam L.,

o. Sarjaras being a resin of Shorea robusta Roth.; and

p. Sesame oil being a oil of Sesamum indicum L,

4. The composition comprising Wakeri-fortified Kampillakadi oil according to claim 3 wherein the Wakeri-fortified Kampillakadi oil is an ingredient of a topical application composition.

5. The composition comprising Wakeri-fortified Kampillakadi oil according to claim 3 comprises one or more composition selected from the group consisting of:

a. a tulle impregnated with Wakeri-fortified Kampillakadi oil. b. an ointment with Wakeri-fortified Kampillakadi oil as at least one ingredient,

c. a liniment with Wakeri-fortified Kampillakadi oil as at least one ingredient,

d. a capsule filled with Wakeri-fortified Kampillakadi oil as at least one ingredient for topical application after pressing out of the oil e. a wound healing spray with Wakeri-fortified Kampillakadi oil as at least one ingredient,

f. a cream with Wakeri-fortified Kampillakadi oil as at least one ingredient, and

g. a gel with Wakeri-fortified Kampillakadi oil as at least one ingredient.

6. The composition comprising Wakeri-fortified Kampillakadi oil according to claim 5 wherein the Tulle comprises a sterile soft oil base made up of open weave woven cotton gauze, a smooth low-adherent non-adhesive wound dressing that allows the wound to drain its exudates.

7. A process of making Wakeri-fortified Kampillakadi oil comprising taking the ingredients in the weights provided below or a variation thereof keeping the relative proportions same, and following steps comprising: a. taking 150 gram each of Vavding powder, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya, Khadirsal, Dhayatiphul, Agaru, Chandan and Wakeri root bark powder, drying the same off and pulverizing the same to a powder, b. soaking the powder in 20 liter water for overnight,

c. adding sesame oil 12.50 kg, Sarjeras 510 gram and 60 liter water, d. boil down the mixture until all water evaporates,

e. wait overnight to settle down the mixture,

f. filter the mixture to obtain the medicated oil.

Description:
WAKERI FOR WOUND HEALING

FIELD OF INVENTION

This invention relates to composition for wound healing. More particularly, the invention pertains to wound healing properties of Wakeri ( Wagatea spicata Dalzell) Wight synonym of Moullava spicata (Dalzell) Nicolson) with Kampillakadi Tailam (CHARAK SAMHITA CHIKITSA STHANAM (CH. CHI.) 25/90); and topical application forms/compositions and devices for its application to wounds.

BACKGROUND OF THE INVENTION

Chronic wound healing is a complicated process which has been described by Velnar et.al. (2009) as follows: “Wound healing remains a challenging clinical problem and efficient wound management is essential. Much effort has been focused on wound care with an emphasis on new therapeutic approaches and the development of technologies for acute and chronic wound management. Wound healing involves multiple cell populations, the extracellular matrix and the action of soluble mediators such as growth factors and cytokines. Although the process of healing is a continuous process, it may be arbitrarily divided into four phases: (i) coagulation and haemostasis; (ii) inflammation; (iii) proliferation; and (iv) wound re-modeling with scar tissue formation. The correct approach to wound management may effectively influence the clinical outcome. (Velnar T. Bailey T. Smrkoli V; The wound healing process: an overview of the cellular and molecular mechanisms, J Int Med Res. 2009 Sep-Oct;37(5): 1528-42).”

Around 2007, a patient was diagnosed with varicose ulcer. He was earlier treated without a relief with state-of-art allopathic medicines comprising ointments of Silver sulphadize, Betadine, various antibiotics, and antihistamines etc. After initial examination he was treated with a polyherbal medicated oil named ‘KAMPILLAKADI T ATT, AM’ which is described in the ancient reference CHARAK SAMHITA CHIKITSA STHANAM (CH. CHI.) 25/90 (25™ CHAPTER 90™ VERSE). The term“TAIL AM” is translation of“oil” in Sanskrut language.

Kampallikadi oil was prepared by collecting all ingredients and as per given process in the grantha (the ancient Ayurvedic scripture) called as“CHARAK SAMHITA CHIKITSA STHANAM (CH. CHI.) 25/90”. Daily dressing was done with gauze piece soaked in the medicated oil. Results were surprising and wound started healing, and over the period of 3 weeks this non healing ulcer healed completely.

It was found desirable to undertake exploration on whether efficacy of Kampallikadi oil can be improved still further for chronic wounds. Thereafter, during routine medical practice, many patients with non-healing wounds and ulcers were treated with topical application forms/compositions and devices of“KAMPILLAKADI T ATT, AM” with good results. Patients who were on allopathy treatment with medicines for topical application, anti-biotics and were not getting relief got good results on wound healing when application of KAMPILLAKADI TAIL AM was started.

However, few cases remained as a challenge which were found to be very difficult to cure. These cases included, without limitation, diabetic wounds, fissure and fistula. Hence, there was a need to improve efficacy of KAMPILLAKADI TAIL AM.

SUMMARY OF THE INVENTION

This invention comprises a composition comprising Wakeri-fortified Kampillakadi Tailam/oil. The Wakeri fortification comprises oil extract of root bark powder of Wakeri being a component in the Kampillakadi oil. Wakeri is a plant species identified by botanical latin name Wagatea spicata Dalzell) Wight synonym of Moullava spicata (Dalzell) Nicolson). Kampillakadi oil/Tailam being a medicinal oil comprising oil extract of Vavding, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya, Khadirsal, Dhayatiphul, Agaru, and Chandan added with Sarjaras. The composition comprising Wakeri- fortified Kampillakadi oil according to claim 3 wherein the Wakeri-fortified Kampillakadi oil is an ingredient of a topical application composition.

The composition comprising Wakeri-fortified Kampillakadi oil comprises one or more composition selected from the group consisting of: (a) a tulle impregnated with Wakeri-fortified Kampillakadi oil, (b) an ointment with Wakeri-fortified Kampillakadi oil as at least one ingredient, (c) a liniment with Wakeri-fortified Kampillakadi oil as at least one ingredient, (d) a capsule filled with Wakeri- fortified Kampillakadi oil as at least one ingredient for topical application after pressing out of the oil, (e) a wound healing spray with Wakeri-fortified Kampillakadi oil as at least one ingredient, (f) a cream with Wakeri-fortified Kampillakadi oil as at least one ingredient, and (g) a gel with Wakeri-fortified Kampillakadi oil as at least one ingredient.

Tulle comprises a sterile soft oil base made up of open weave woven cotton gauze, a smooth low-adherent non-adhesive wound dressing that allows the wound to drain its exudates. This invention also comprises a process of making Wakeri-fortified Kampillakadi oil comprising taking the ingredients in the weights provided below or a variation thereof keeping the relative proportions same, and following steps comprising: (a) taking 150 gram each of Vavding powder, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya, Khadirsal, Dhayatiphul, Agaru, Chandan and Wakeri root bark powder, drying the same off and pulverizing the same to a powder, (b) soaking the powder in 20 liter water for overnight, (c) adding sesame oil 12.50 kg, Saijaras 510 gram and 60 liter water, (d) boil down the mixture until all water evaporates, (e) wait overnight to settle down the mixture, (f) filter the mixture to obtain the medicated oil, and (g) 2.5 gram of Butyl athy dr oxytoluene (BHT),

DETAILED DESCRIPTION OF THE INVENTION

Brief Description of Figures and Legends: Figure 1: Treatment of Psoriatic wounds on legs with Wakeri-impregnated Kampillakadi oil.

Figure 1(a): Legs before application of the Wakeri-impregnated Kampillakadi oil Figure 1(b): Legs one month after application of the Wakeri-impregnated

Kampillakadi oil three times a day

Figure 1.1: Treatment by Wakeri-fortified Kampallikadi oil of infected itching figures of a domestic help due to wetness

Figure 1.1(a): Figures prior to treatment Figure 1.1(b): Same figures 5 days after treatment

Figure 1.2: Use of Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil for treating chronic infected fissure of a non-diabetic patient

Figure 1.2(a): On day 3 rd - slough was gone [Figure 1.2(b)]: Proliferation tissue started on day 7

[Figure 1.2(c)]: On lO* 11 day granulation started

[Figure 1.2(d)]: wound got healed completely in 20 days Figure 1.3: Use of Tulle impregnated with Wakeri-fortified

KAMPILLAKADI oil for treating post- cancer-surgical infected wound of a non-diabetic patient

Figure 1.3(a): Cancer-surgical wound infected on 28* Hg of surgery. To this Tulle impregnated with Waken Oil was applied.

[Figure 3(b)] Response on 6 th day

[Figure 3(c)] Granulation and proliferation tissue started forming fast, [Figure 3(d)] The wound got contracted and within 30 days it got healed completely. Figure 1.4: Use of Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil for treating lacerated wound after small accident of a - diabetic patient

[Figure 4(a)]: A lacerated diabetic wound after a small accident on account of improper care on day of starting the treatment [Figure 4(b)] Mild edema and inflammation observed on I st day got healed on 4 th day.

[Figure 4(c)]: In next 3 days i.e. on 7 th day wound healing was significantly faster

[Figure 4(d)]: The wound healed very fast in few days thereafter. Figure 2: PHARMACODYNAMICS - Schematic representation of Herbal Tulle 1. Tulle - Non-adhesive dressing

2. Wound ventilation below the mesh

3. Better drainage of exudates

4. Wound surface

5. Re si stant to b acted a

6. Maintains moisture in tissue below wound

It was surprisingly found that when hydro alcoholic extract of root bark of WAKERI ( WAGATEA SPICATA ) was mixed with KAMPILLAKADI TAIL AM and applied to the above very difficult cases, results obtained were:

1. Decrease in percentage of wound exudates,

2. Decrease in percentage of pain along with inflammation,

3. Increase in percentage of formation of Granulation, and

4. Wound approaches proliferation stage faster.

We conducted Liquid Chromatography Mass Spectrometry hydro alcoholic extract of waken root bark. More than 80 phyto-constituents were detected, some of which are known to be:

• Antibiotic, Antiviral,

• Antihistaminic,

• Steroids, anti-inflammatory ,

• Neuro transmitters,

• Cell growth enhancer, Intracellular calcium enhancers ,

• Bioactive lipid mediator; etc. Above all activities are very much necessary for any type of wound healing. Hence, adding Wakeri root bark extract to KAMPILLAKADI T ATT, AM was contemplated. Oil was prepared and tried on 10 patients.

Results on wound healing by using WAKERI FORTIFIED KAMPILLAKADI TAILAM was observed to be much faster when compared to application of only KAMPILLAKADI TAILAM in following respects:

1. decrease in % of foul smell, and

2. Overall wound closure time using WAKERI FORTIFIED KAMPILLAKADI TAILAM was observed to be faster by about 20 to 30% when compared to application of only KAMPILLAKADI T ATT, AM

Details of Table 2 describes ingredients and composition of KAMPILLAKADI oil original reference from CHARAK SAMHITA CHIKITSA STHANAM (CH. CHI.) 25/90. This oil contains following ingredients: Vavdinga, Kutaj, Kapilla, Trifala, Bala, PatolPatra, Nimsal, Lodhra, Nagarmotha, Priyangu, Khadirsal, DhayatiFul, Saijaras, Agaru and Chandan.

The Medicinal properties of its ingredients are given as follows

• Vavdinga ( Emblica ribes), Kapila (Mai lotus philippwnis) and Kutaj ( Holarrhena antidysenterica ) have antifungal, anti-amoebic activity and activity against Gram Positive and Gram Negative infections. (http://www.ibiopharm.com/index.php/aibps/article/view/24

http://www.ncbi.nlm.nih.gov/pubmed/24l82990 ) Neem - Well known antifungal, one of the most powerful blood purifiers and detoxifiers in Ayurvedic usage, Neem is often used to maintain healthy skin (http://www.ncbi.nlm.nih.gov/pubmed/26l95902). Neem is known to boost the immune system by energizing lymphocytes cells to respond to infection and other challenges to the body's immunity.

Triphala - Another Ayurvedic multipurpose aid for digestion, Triphala is a traditional combination of three myrobalan fruits: Amla, Haritaki and Vibhitaki. Decoction is used also for skin infections, removal of wound debris (http://www.ncbi.nlm.nih.gov/pubmed/l9H8845).

Chandan - Santalam album Bark used for healthy skin and cooling effect.

Raal (It’s a resin from“ Shorea robusta”) Best for bums having healing effect and as a cooling agent, and for overcoming foul smell http://www.ncbi.nlm.nih.gov/pubmed/26030465

Nagarmotha- ( Cyperus rotundus- bulbous roots used) Healing activity and cooling agent.

It was a surprising finding, in one embodiment of this invention, that addition of root bark powder of Waken ( Wagatea spicatd) in the KAMPILLAKADI TAILAM improved its healing capability still further particularly for difficult to heal chronic wounds described above and various skin diseases it was a surprising observation that when powder of the root bark of the Wakeri is added to KAMPILLAKADI oil and when this oil is applied on a chronic wound, the wound got healed within 7 days whereas in treatment with KAMPILLAKADI oil alone it normally takes more than 10 to 12 days. The improvement in effect due to addition of extract of root bark of Wagatea spicata to KAMPILLAKADI oil was spectacular.

In another embodiment of this invention the hydro-alcoholic bark extract of Wakeri was subjected to HPLC (High Pressure Liquid Chromatography) detected presence of more than 80 phytochemicals. The important ones were also assigned for their therapeutic effect. Some of them are as follows:

Table 1

This is very significant observation since modern medicines and antibiotics or antiseptics do the job of controlling microbiological infections, but the process of “healing” is performed by the body; and this healing process, which is not within the scope of modern medicines, is facilitated by Warkeri-fortified KAMPILLAKADI oil. In this case, the fortified KAMPILLAKADI oil enriched with root bark powder of Waken not only controlled microbiological infection in the wound but also reduced edema and exudates and enhanced granulation tissue formation process. Healing process is faster with application of the Wakeri- fortified KAMPILLAKADI Oil.

According to Surange and Deokule (1987) (S. R. Surange and S. S. Deokule, PHARMACOGNISTIC STUDIES ON Wagatia spicata DALZELL, AncSci Life. 1987 Apr-Jun; 6(4): 238-243.), Waken, a climbing shrub, belongs to family

Leguminosae (Caesalpiniaceae) known in vernacular as‘Wagati” or“Wakeri. According to Indiabiodiversity.org, Wakeri is ( Wagatea spicata Dalzell) Wight synonym of Moullava spicata (Dalzell) Nicolson (refer the link http://indiabiodiversity.org/species/show/264763). It is a monotypic genus of a robust woody, climbing shrub growing abundantly in Maharashtra State, especially in Konkan jungles and on the Ghats near Mahabaleshwar. The roots are known to be used in the treatment of pulmonary tuberculosis and pneumonia since long in the Indian system of medicine. The bark is used for skin diseases. This has been renamed as Moullava spicata (Dalzell) in 1851. This invention, for the first time has identified the efficacy of Wakeri root bark extract for its chronic would healing properties.

In view of the complications in chronic wounds and limitations of currently available Allopathic antibiotics, anti-infective and antiseptics, this development provides a remedy that was not available earlier for diabetic and other patients, healing chronic wounds for whom is a challenging task.

Root bark powder of Wakeri is one embodiment of this invention. Wakeri fortified KAMPILLAKADI oil is another embodiment of this invention. A process of making of Waken fortified KAMPILLAKADI oil is a further embodiment of this invention.

The above formulation of Wakei fortified Kampillakadi oil as described in Example 3 below has following properties: · Having efficacy for healing most of NON HEALING WOUNDS,

ULCERS , BURNS,

• Having ANTIBACTERIAL, ANTIVIRAL activity.

• Helps to reduce ERYTHEME and EDEMA.

• Formulation of granulation tissue is fast at least 20 to 30% more compared to other external wound healing agents.

Traditionally, in Ayurveda, the wound healing oils are applied as plain oils on the wound and dressing the same. It is an embodiment of this invention wherein an Ayurvedic wound healing oil is provided in the latest embodiment/device of dressing for the wounds: the“Tulle”. (Non Adhesive Dressing). “TULLE” is a Non Adhesive Dressing, used in Allopathy for non-healing wounds or ulcers or urns. In one aspect, this invention comprises a“Tulle” of herbal oil (see Figure 1).

Tulle typically comprises of:

• Soft oil base made up of woven cotton. • To this is applied Polyherbal Kampillakadi oil fortified with root bark powder of Wakeri as one of the ingredients.

• Tulle is a sooth and low-adherent non-adhesive wound dressing that allows the wound to drain its exudates.

• Wound Healing oil dressing is a sterile Tulle made from open weave gauze;

• Antiseptic /Wound Healing efficacy of tulle is unaffected by presence of blood or serum at the wound site.

• Reduces the risk of bacterial colonization

• Tulle is made sterile using gamma irradiation.

• Herbal formulation has not only antimicrobial activity but enhances “HEALING” also.

• Healing is body reaction. Modern medicines don’t have healing activity, they have only antibacterial and smoothening activity. This herbal formulation has, surprisingly, shown a enhanced wound healing activity as per claims.

In summary, Tulle comprises a sterile soft oil base made up of open weave woven cotton gauze, a smooth low-adherent non-adhesive wound dressing that allows the wound to drain its exudates. Tulle impregnated with Wakeri -fortified KAMPILLAKADI oil may be used in the management of wounds, including minor traumatic injuries, ulcers, burns, and other lesions that are clinically infected by organisms shown to be sensitive to sesame oil

Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil is contra-indicated in patients who are allergic to sesame oil, or who have previously demonstrated a sensitivity to sesame oil, or any other chemically related product. The dressing should not be used in the treatment of wounds that are free of clinical infection.

It is an embodiment of this invention that the“Tulle” comprising Waken fortified Polyherb al KAMPILLAKADI oil having wound Healing activity and the same is useful as a remedy for following indications · Minor bums and scalds

• Lacerations, abrasions and other skin loss wounds

• Bed sores

• Diabetic wounds

• Non Healing ulcers

· Donor and recipient graft sites

• Leg ulcers, where the wound is no more than 10% of the body area, where there is a risk of infection, or on already infected wounds in conjunction with systemic antibiotics

• Traumatic: Lacerations, abrasions, grazes (gravel rash), bites (animal and insect), cuts, puncture wounds, crush injuries, surgical wounds and incisions, traumatic ulcers.

• Ulcerative: Varicose ulcers, diabetic ulcers, bed-sores, tropical ulcers. Thermal: Bums, scalds.

• Elective: Skin grafts (donor and recipient sites)of finger or toe-nails, circumcision.

• Miscellaneous: Secondary infected skin conditions, e.g. eczema, dermatitis, herpes zoster, colostomy, acute paronychia, incised abscesses

(packing), in growing toe-nails.

Direction for use of the“Tulle” of this invention are as follows: Clean the wound. Following this a single tulle dressing should be applied directly to the wound. Cover with an appropriate dressing. In the case of ulcers it is advisable to cut the dressing exactly to the size of the ulcer and not to overlap onto the surrounding epidermis. When the lesion is very exudative it is advisable to change the dressing at least once day; otherwise it may be left in situ for 2 - 3 days.

Cross-sensitization to medicated oil may occur in patients known to be allergic to sesame oil. In normal use, absorption of oil from Tulle impregnated with Wakeri fortified KAMPILLAKADI oil is negligible; however, where large areas of the body are being treated, the possibility of ototoxicity caused by prolonged application should be considered.

Pack Shot Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil is presented individually wrapped in an aluminum peel pouch, manufactured under aseptic conditions. Tulle impregnated with Wakeri -fortified KAMPILLAKADI oil should be stored in a cool place.

Following sizes of Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil may be appropriate for most wounds: 10 cm x 10 cm*and 10 cm x 30 cm. Wakeri-fortified KAMPILLAKADI oil can be used as an Active Pharmaceutical Ingredient (API) for making various topical application forms/compositions and devices; in addition to its use for making non-adhesive dressing - Tulle. Illustrative dosage forms that can be envisaged to be made by use of Wakeri- fortified KAMPILLAKADI oil as an API include, without limitation, ointment, liniment, wound healing spray, cream, gel and the like. A person skilled in the art knows the methods of making above listed compositions; in which Wakeri- fortified KAMPILLAKADI oil is required to be added as an API.

In the following are given non-limiting illustrative examples of various embodiments of this invention and efficacy of Wakeri-fortified KAMPILLAKADI oil applied on Tulle. From this, a person skilled in the art would readily understand the allied indications that can be treated with Wakeri- fortified KAMPILLAKADI oil with Tulle; and all of them are covered within the scope of this specification.

From the examples given below, it shall be clearly apparent to a person skilled in the art that chronic wounds of diabetic patients, fissures and fistula will also be healed by the Wakeri-fortified Kampillakadi oil. Examples

Example 1

Making Kampillakadi Tailam/Oil, Ch Chi 25/90

Table2: Ingredients and composition of KAMPILLAKADI oil adapted from original reference from CHARAK SAMHITA CHIKITSA STHANAM (CH. CHI.) 25/90. This oil contains extracts from following ingredients, which are vernacular names of medicinal plants recognized in CHARAK SAMHITA CHIKITSA STHANAM (CH. CHI.) 25/90: Vavdinga, Kampillaka, Kutaj, Trifala, Bala, PatolPatra, Nimsal, Lodhra, Nagarmotha, Priyangu, Khadirsal, DhayatiFul, Sarjaras, Agaru and Chandan.

Method of preparation:

Ingredients numbered from 1 to 16 except no.13 are taken, dried well and pulverized to make a powdered mixture. The powder mixture is soaked for overnight in 20 L of water. Then sesame oil and balance water (60 liter) is added and ingredient no 13 is also added. The mixture is boiled down until all water gets evaporated, allowed to settle overnight and filtered off to make free from the sediment to obtain a medicated oil. To the medicates oil, ingredients 17 & 18 are added.

Example 2

Making root bark powder of Wakeri spicata

1. Please identify Wakeri ( Wagatea spicata ) especially in flowering season

2. Dig out roots and cut in to pieces. Separate root bark.

3. Wash it clean and sun dry till it gets dried.

4. Pulvarize

Example 3

Making Wakeri spicata fortified KAMPILLAKADI TAILAM/OIL

• Take 150 gram each of Vavding powder, Kutaj, Kapilla, Trifala, Patolpatra, Bala, Nimsal, Lodhra, Nagarmotha, Charolya,

Khadirsal, Dhayatiphul, Agaru, Chandan, and Wakeri root bark powder dry well and pulverize to a powder.

• Soak the whole powder in 20 liter water for overnight, add sesame oil 12.5 kg and 150 gram Sarjeras and 60 liter water. Boil down the mixture until all water evaporates. Wait overnight to settle down the mixture. Filter the mixture to obtain the medicated oil. Then add 2.5 gram of Butyl athydroxytoluene BHT).

Example 4

Case Studies (4.1) A domestic help of the age of 45 years was suffering from itching and inflamed fingers due to wetness for a long time everyday due to work involving cleaning kitchen utensils (Figure l. la). She got relief within 5 days from application of the Waken fortified KAMPILLAKADI oil (Figure l.lb).

(4.2) Same patient had a fungal foot infection too on account of same reason; who got cured within 7 days of the application of the Wakeri fortified oil.

(4.3) A female patient 50 years old was suffering from Psoriasis for more than a year, lesions were formed on all over the body especially on both legs. There was severe itching. She was under allopathic medicinal treatment with various steroids and topical applications but was getting temporary results only. The Psoriatic wounds were having pain, oedema and got infected also due to itching [Figure 1(a)] This patient started applying Wakeri-fortified KAMPILLAKADI. Application was done thrice in a day. Results obtained on 40 th day [Figure 1(b)] were as follows:

• Dry skin Scaling reduced

· Oedema reduced Itching stopped completely

• Wound started healing in a week time and completed healing in a month.

• Whenever application was stopped for some reasons, the itching and scaling started again; but again wounds healed and scaling reduced when oil application was restored.

Example 5

Tulle impreganted with Wakeri-fortified KAMPILLAKADI OIL

Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil consists of a cotton leno-weave fabric impregnated with oil. It is prepared in the same fashion as known to the person skilled in the art except that it is further impregnated with Wakeri-fortified Kampillakadi oil.

The dressing is used as a primary wound contact layer in the management of infected wounds, combining low adherence to the wound and with antimicrobial activity. The wound is cleansed with a suitable sterile solution, such as normal saline; a single layer of Tulle. Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil is then applied and covered with an absorbent pad, held in place with tape or a bandage, as appropriate. When used to dress ulcers, Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil is shaped to fit the crater and not allowed to extend over the surrounding skin. The frequency of dressing changes will depend entirely upon the nature of the wound, but infected wounds that are exuding heavily should be dressed at least once a day.

EXAMPLE 6 Use of Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil for treating chronic infected fissure of a non-diabetic patient

A non-diabetic patient, was suffering since 2 years from chronic infected fissure; wherein the track of the fissure, for which surgery was also done, was not responding to antibiotics and any other treatment at all. In course of time it had got heavily infected. This wound was washed with normal saline and Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil containing composition of this invention was applied on it. It was observed that very much rapid granulation tissue developed. On day 3 rd itself slough was gone [Figure 1.2(a)] Proliferation tissue started on day 7 [Figure 1.2(b)] On 10* 11 day granulation started [Figure 1.2(c)] and wound got healed completely in 20 days [Figure 1.2(d)]

EXAMPLE 7

Use of Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil for treating post- cancer-surgical infected wound of a non-diabetic patient A 42 year old non-diabetic male patient having undergone surgery for cancer had post-operative wound on cheek which was not responding to normal dressing for about a month, oozing of fluid had started from the wound. There was no response to antibiotics (Amoxicillin 55mg+clavuminic acid 100 mg BD) and anti- histaminics (CetirizinelO mg 1 BD). This patient was treated on 28* ^g of surgery [Figure 3(a)] by applying Tulle impregnated with Wakeri Oil. The wound started showing response from 6 th day [Figure 3(b)] Granulation and proliferation tissue started forming fast, [Figure 3(c)] the wound got contracted and within 30 days it got healed completely [Figure 3(d)]

EXAMPLE 8

Use of Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil for treating lacerated wound after small accident of a -diabetic patient

A 50 year old non-diabetic patient had a lacerated diabetic wound after a small accident. The wound became lacerative on account of improper care [Figure 4(a)] No treatment was given to this wound prior to giving treatment with Wakeri Oil impregnated Tulle. Mild edema and inflammation observed on I st day got healed on 4 th day [Figure 4(b)] In next 3 days i.e. on 7 th day wound healing was significantly faster [Figure 4(c)] than as compare to I st 3 days. Thus, it was shown that for superficial lacerations, abrasions, the wound heals very fast [Figure 4(d)]

EXAMPLE 9

Use of Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil for non-diabetic patient affected by trauma followed by infected wound due to non dressing and keeping the wound open A 34 year old non-diabetic male was affected by trauma followed by infected wound due to non dressing and keeping the wound open. This wound was not responding to local applications of Betadine preparations and silver sulfadiazine preparations and topical applications for 15 days. On 16 th day, Tulle impregnated with Wakeri-fortified KAMPILLAKADI oil was applied to the wound. The inflammation came down very rapidly. Slough got debride. Wound closure occurred and contraction started on 6 th day .On l8 th day the wound got completely healed.