FORM – 2
THE PATENTS ACT, 1970
(39 of 1970) &
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
A HERBAL BASED MEDICINAL COMPOSITION
Ari Healthcare Pvt. Ltd.
an Indian Company of Office No. 106, Matrix, S. No. 1, Opp. Eon SEZ, Kharadi, Pune-411014,
Maharashtra, India.
Inventors:
1. NIPANIKAR SANJAY
2. KANJILAL ANISHA
3. KANJILAL SANJEEVAN
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED.

FIELD:
The present disclosure relates to a herbal based medicinal formulation.
BACKGROUND:
Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products that contain as active ingredients, parts of plants, or other plant materials, or combinations. As people are becoming aware of the potency and side effect of synthetic drugs, there is an increasing interest in the natural product remedies. Herbal medicines are currently in demand and their popularity is increasing day by day. In the healthcare sector, WHO recommends and encourages the use of traditional herbs/remedies because of huge amount of raw material is easily available and they are comparatively safe due to their low toxicities.
Wound is defined as a physical injury that results in loss or breaking of cellular, anatomic or functional continuity of living tissue. Healing of wound is a complex process that requires support at three levels such as epithelialization, contraction and connective tissue (matrix) deposition. Epithelialization is a process where keratinocytes migrate from the lower skin layers and divide. Contraction is the process of narrowing or closing of the wound. Connective tissue and matrix deposition is the process which produces new matrix and collagen.
Wound healing process starts from the moment of injury and can continue for varying periods of time depending on the extent of wounding. Accordingly, wound is classified as acute wound and chronic wound. Acute wounds are usually tissue injuries that heal completely, with minimal scarring, within the expected time frame, usually 8–12 weeks, while chronic wounds, generally failed to progress through the normal stages of healing and are trapped in an early stage of wound healing with excessive inflammation.
Singh et.al, in the article titled “Antimicrobial potential of polyherbo-mineral formulation Jatyadi taila-A review” (International Journal of Research in Ayurveda and Pharmacy: 291, Jan-Feb 2011, 151-156) summarizes the antimicrobial activity of polyherbo-mineral formulation (Jatyadi oil). In Ayurveda, Jatyadi oil formulation mainly contains Curcuma longa, Azadirachta indica, Symplocos racemosa, Jasminum auriculatum, Sesamum indicum and copper.

Hema Sharma Datta et. al., summarizes in the article titled “ Wound healing activity of topical application forms based on Ayurveda” (Evidence based complementary and alternative medicine vol 2011, Article ID 134378), topical anti-aging formulation contains cow ghee, flax seed oil, Phyllanthus emblica fruits, Shorea robusta resin and Yashada Bhsama. The group treated with the formulation containing Yashada bhasma along with Shorea robusta resin and flax seed oil showed significantly better wound contraction, higher collagen content and better skin breaking strength as compared to control group.
Garg and Paliwal in the article titled “Wound healing activity of ethanolic and aqueous extracts of Ficus bengalensis” (Journal of advanced pharmaceutical technology and research, vol 2, issue 2 , Apr-June 2011) and Juraiporn somboonwong in the article titled “Wound healing activities of different extracts of Ficus bengalensis and Centella asiatica in incision of burn wound models: an experimental animal study"(BMS complementary &alternative medicine 2012, 12:103) summarizes the wound healing activity of different extracts of Ficus bengalensis and Centella asiatica.
Previously used formulation has wound healing effect along with epithelialization and keratinization. However, there is a need to develop an herbal based medicinal formulation which can act synergistically for wound healing remedy and which is capable of accelerating the process of wound healing by increasing cellular proliferation, forming granulation tissue and synthesizing collagen.
OBJECTS:
Some of the objects of the present disclosure which at least one embodiment is adapted to provide, are described herein below:
It is an object of the present disclosure to provide a synergistic herbal based medicinal formulation which is effective in treating wounds, cuts, burns, inflammation and various skin diseases/disorders.
It is another object of the present disclosure to provide a medicinal formulation which is prepared from natural product sources.
It is still another object of the present disclosure to provide a medicinal formulation which is safe, non-irritating and non-toxic to skin.

It is still further an object of the present disclosure to provide a stable medicinal formulation which provides ease of application with high penetrability.
It is still further an object of the present disclosure to provide a medicinal formulation which is cost effective.
SUMMARY
The present disclosure provides a herbal based synergistic formulation comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 10 wt%;
ii. Ficus bengalensis in an amount ranging from 0.1 to 7wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 8 wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 8 wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.1 to 7 wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 6 wt%;
vii. Pongamia pinnata in an amount ranging from 0.1 to 5 wt%;
viii. Jatyadi oil in an amount ranging from 0.5 to 10 wt%;
ix. Yashada bhasma in an amount ranging from 0.1 to 4 wt%; and
x. at least one pharmaceutically acceptable excipients.
In accordance with the present disclosure the formulation is in a dosage form selected from the group consisting of a cream, a lotion, a gel, powder, a paste, and an ointment.
In accordance with another aspect of the present disclosure there are provided processes for the preparation of herbal based synergistic formulations.
GEOGRAPHICAL DETAILS OF THE PLANT SOURCE:
Ficus religiosa (Moraceae)
Description: It is traditionally known as ‘Peepal tree’. It is widely branched tree with leathery, heart-shaped, long-tipped leaves on long slender petioles and purple fruits growing in pairs.
Synonym: Ashvattha, Sacred fig, Peepal, Arayal, Ravi and Arasu
Geographical source: Ficus religiosa or Sacred Fig is species of fig native to India, Bangladesh, Nepal, Pakistan, Sri Lanka, southwest China and Indochina.

Chemical constituents: tannins, saponins, flavonoids, steroids, terpenoids, polyphenols and cardiac glycosides, bergapten, bergaptol, lanosterol, β-sitosterol, stigmasterol, lupen-3-one, β-sitosterol-d-glucoside (phytosterolin), vitamin k1 . The bark also contains tannin, wax, saponin, β-sitosterol, leucocyanidin-3-0-β-D-glucopyrancoside, leucopelargonidin- 3-0-β-D glucopyranoside, leucopelargonidin-3-0-α-L- rhamnopyranoside, lupeol, ceryl behenate, lupeol acetate, α-amyrin acetate, leucoanthocyanidin and leucoanthocyanin Uses: Astringent, aphrodisiac, antibacterial, anti-inflammatory and anti-emetic.
Ficus bengalensis (Moraceae)
Description: It is fast growing, evergreen tree found in monsoon and rain forests grow up to 30 meters.
Synonym: Banyan Tree, Nyagrodha, Vada and Paranika,
Geographical source: It is native to India, Bangladesh, Nepal, Pakistan, Sri Lanka, southwest China and Indochina.
Chemical constituents: leucopelargonidin -3-0- x-L rhamnoside, leucocynidin. 3-0-x-D galactosyl cellobioside, glucoside beta glucoside, 20-tetratria conthene-2- one, 6- hepatatria contene-10-one and pentatricentan, and polyphenols
Uses: Roots shows anthelmintic activity. The extracts also reported to inhibit insulinase activity from liver and kidney. Fruit extracts exhibits anti-tumor activity and antibacterial activity. The bark is used in inflammation, swelling at neck, gonorrhea, scabies, mouthwash for tooth ache, and for strengthening gums.
Centella asiatica (Apiaceae)
Description: It is a perennial, herbaceous creeper with kidney shaped leaves. Synonym: gotu kola, Hydrocotyle asiatica and Mandukaparni
Geographical source: It is native to India, Sri Lanka, Madagascar, South Africa, Australia, China and Japan.
Chemical constituents: Centella contains several active constituents, of which the most important are the triterpenoid saponins, including asiaticoside, centelloside, madecassoside, polyphenols and asiatic acid. In addition, it contains other components, including volatile oils, flavonoids, tannins, phytosterols, amino acids and sugars.

Uses: The herb is recommended for the treatment of various skin conditions such as leprosy, lupus, varicose ulcers, eczema, psoriasis and the like.
Shorea robusta (Dipterocarpaceae)
Description: It is a large, deciduous tree up to 50 m tall
Synonym: Sal, shala, sakhu, borsal, hal and sagua.
Geographical source: This tree is native to the Indian Subcontinent, ranging south of the Himalaya, from Myanmar in the east to Nepal, India and Bangladesh.
Chemical constituents: tri-terpenoids, sterols, polyphenols and resins.
Uses: Shorea robusta resin with Beeswax is used as a base for ointment of herbal extracts used in the healing of foot cracks, psoriasis and other chronic skin diseases. It is useful in treating wounds, ulcers, neuralgia, burns, pruritus and various skin problems. A combination of cow ghee, Shorea robusta resin along with selected herbal ingredients can be applied in rectal prolapse, hemorrhoids, burns and other injuries to control burning sensation.
Glycyrrhiza glabra (Fabaceae)
Description: It is a hard herb attaining a height up to 6ft; leaves multifoliate, imparipinnate, flowers in axillary spikes, papilinaceous, and lavender to violet in color, pods compressed and containing reform seeds.
Synonyms: Liquorice, Sweet wood and Jeshtamadha
Geographical origin: Native to central south western Asia, South Europe and India. Chemical Constituents: The major bio-active constituents of rhizomes are triterpenoids saponin, glycyrrhizin, glycyrrhizinic acid, glabrin A and B, glycyrrhetol, glabrolide, isoglabrolide, isoflavones, coumarins triterpene, polyphenols and sterols.
Uses: Tonic, demulcent, expectorant, mild laxative, anti-arthritic, anti-inflammatory, antibiotic, anti-viral, anti-ulcer, memory stimulant (being MAO inhibitor), anti-tussive, aphrodisiac, estrogenic, anti-oxidant, anti-caries agent, anti-neoplastic, anti-cholinergic, anti-diuretic and hypo-lipidemic activity.
Azadirachta indica (Meliaceae)
Description: It is a fast-growing evergreen tree that can reach at a height of 15–20 m. Synonym: Neem, Nim, Nimm, Arya Veppu, Azad, Nimba, Kadu-Limba and Margosa.

Geographical source: It is native to India and China.
Chemical constituents: Nimbin, nimbinin, nimbidin, azadirachtin, and polyphenols.
Uses: anthelmintic, antifungal, antidiabetic, antibacterial, antiviral, contraceptive and sedative. Neem products are also used in selectively controlling pests in plants.
Pongamia glabra (pinnata) (Leguminosae)
Description: Pongamia glabra (pinnata) is commonly known as 'Karanj'. It grows about 15-20 meters in height with a large canopy which spreads equally wide.
Geographical source: It is native to tropical and temperate Asia including part of India, China, Japan, Malaysia and Australia.
Synonyms: karanja, pongam and dalkaramch.
Chemical constituents: beta-sitosteryl acetate and galactoside, stigma sterol, its galactoside and sucrose, unsaturated fatty acids, oleic acid, stearic acid palmitic acid, hiragonic, octadecatrienoic acid, Karangin, pongamol, pongagalabrone pongapin, pinnatin, polyphenols and kanjone. The leaves and stem of the plant consist of several flavone and chalcone derivatives such as pongone, galbone, pongalabol and pongagallone A and B.
Use: Leaves can be used as an anthelmintic, digestive, anti-inflammatory and laxative. It is also used for colds, coughs, diarrhea, dyspepsia, flatulence, gonorrhea and leprosy.
Jatyadi Taila:
Jatyadi oil is polyherbo-mineral composition which is used in wound healing composition. The oil comprises Curcuma longa, Azadirachta indica, Symplocos racemosa, Jasminum auriculatum, Sesamum indicum and copper.
Yashada Bhasma:
Yashada Bhasma (Processed zinc) is a traditional mineral preparation, which plays an important role in the normal functioning of skin as it influences the synthesis of collagen. Epithelialization of burns may be improved by zinc treatment. Literature describe the activities of Yashada bhasma as Krimighna (antimicrobial), Kantikara (improves complexion), Rasayana (rejuvenator) and Grahi (improves moisture holding capacity of skin).

It also improves the binding power of the cells of skin soft tissues, improves cell migration and cell regeneration and hastens wound healing.
DETAILED DESCRIPTION:
In accordance with the present disclosure, there is provided a herbal based synergistic medicinal formulation which is effective in treating wound, cuts, burns, inflammation, infections and various skin conditions/diseases/disorders. Previously, it has been revealed that wound healing is a complex process which typically, involves an acute inflammatory phase followed by synthesis of collagen and other extracellular macromolecules that are later remodeled to form scar.
Therefore, in the quest for the development of an effective wound healing composition for management and treatment of wounds, the inventors of the present disclosure studied various botanicals having medicinal properties such as anti-inflammatory, anti-microbial, astringent, wound healing, anti-ulcer and antiseptic. These botanicals are selected from the group consisting of Ficus religiosa, Ficus bengalensis, Centella asiatica, Shorea robusta, Glycyrrhiza glabra, Azadirachta indica, and Pongamia glabra (pinnata).
Furthermore, the inventors developed various compositions containing aforementioned botanicals or the substance derived from these botanicals along with jatyadi oil and yashad bhasma. The copper present in the Jatyadi oil and zinc present in the Yashad bhasma stimulate collagen and elastin production in the dermis of the skin and the aforesaid botanicals or the substances provide anti-inflammatory and antiseptic activities.
In view of these preliminary findings, the inventors conducted further experiments to develop a wound healing formulation consisting of specific active ingredients which can produce enhanced wound healing effect.
It is found that the wound healing formulation of the present disclosure stimulates cellular proliferation, forms granulation tissue and synthesizes collagen, which in turn gives enhanced wound healing activity in a quick time period.
In accordance with one aspect of the present disclosure, there is provided a wound healing formulation consisting of:
a) Ficus religiosa;
b) Ficus bengalensis;

c) Centella asiatica;
d) Shorea robusta;
e) Glycyrrhiza glabra;
f) Azadirachta indica;
g) Pongamia glabra (pinnata);
h) Jatyadi oil;
i) Yashada bhasma; and
j) at least one pharmaceutically acceptable excipient.
In one embodiment of the present disclosure Ficus religiosa, Ficus bengalensis, Centella asiatica, Shorea robusta, Glycyrrhiza glabra Azadirachta indica and Pongamia glabra (pinnata) are in the form of extract. The extract is selected from the group consisting of alcoholic extract, aqueous extract and hydro-alcoholic extract. The extract is derived from plant part which includes but is not limited to leaves, seeds, stem, branches, bark, roots, rhizomes, whole plant and combinations thereof.
The individual extract can be in the form of a solution, an emulsion, a suspension, powder, semisolids, isolated fraction and oil.
The extract is prepared by using techniques selected from the group consisting of soxhlet extraction, percolation, decoction, maceration and supercritical fluid extraction.
Provided herein below the locations from where the actives are collected.

Actives Location
Ficus religiosa extract Indore
Ficus bengalensis extract Indore
Centella asiatica extract Ahmedabad
Shorea robusta extract Indore
Glycyrrhiza glabra extract Ahmedabad
Azadirachta indica extract Indore
Pongamia pinnata extract Ahmedabad
Jatyadi oil Thane (Maharashtra)
Yashada bhasma Uttar Pradesh

In one embodiment the formulation consisting of Ficus religiosa in an amount ranging from 0.5 wt% to 10 wt%; Ficus bengalensis in an amount ranging from 0.1 wt% to 7 wt %; Centella asiatica in an amount ranging from 0.5 wt% to 8 wt%; Glycyrrhiza glabra in an amount ranging from 0.1 wt% to 7 wt% Azadirachta indica in an amount ranging from 0.1 wt % and 6wt %; Pongamia glabra (pinnata) in an amount ranging from 0.1 wt% to 5 wt %; Shorea robusta in an amount ranging from 0.5 wt% to 8 wt %; Jatyadi oil in an amount ranging from 0.5 wt% to 10 wt % and Yashad bhasma in an amount ranging from 0.1wt% to 4wt%; and at least one pharmaceutically acceptable excipient. The amount of each ingredient is based on the total mass of the formulation.
The formulation is in a dosage form selected from a group consisting of a cream, a gel, powder, a suspension, an emulsion, a paste, a lotion, and an ointment.
The pharmaceutical excipients used in the formulation of the present disclosure include but are not limited to vehicles, solvents, diluents, surfactants, wetting agents, emulsifiers, waxes, humectants, gelling agents, stabilizers, preservatives, lubricants and combinations thereof.
The emulsifier used in the present formulation is selected from the group consisting of cetostearyl alcohol, glyceryl monostearate, polyglyceryl isostearte, hexyl laurate, dimethicone and combinations thereof. The preservative used in the present formulation is selected from the group consisting of methylparaben sodium, propylparaben sodium and combinations thereof. The stabilizer used in the present formulation is selected from the group consisting of disodium edetate, propyl gallate, butylated hydroxyanisole, butylated hydroxytoluene, citric acid, ascorbic acid, sodium ascorbate and combinations thereof.The gelling agent used in the present formulation is selected from the group consisting of carbomer, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxy methyl cellulose, hydroxyethyl cellulose, carbopol polyethylene glycol, acrylates, methacrylates, gelatin, alginates, pectins, tragacanth, karaya gum, xanthan gum, carrageenin, agar, alginate, chitosan, acacia and combinations thereof.
In accordance with the present disclosure, the wax is selected from the group consisting of hard paraffin, soft paraffin, oil, paraffin wax and combinations thereof. The humectant used in the present formulation is selected from the group consisting of glycerin, alpha hydroxyl acids, glyceryl triacetate, propylene glycol, honey and combinations thereof.

The diluent is selected from the group consisting of microcrystalline cellulose, starches, lactose, mannitol, calcium phosphate, dibasic calcium phosphate and mixture thereof.
In one embodiment the formulation is in the form of a cream, said cream comprising:
i. Ficus religiosa in an amount ranging from 2.0 to 4.0wt%, preferably 3wt%;
ii. Ficus bengalensis in an amount ranging from 1.0 to 3.0wt%, preferably 2wt%;
iii. Centella asiatica in an amount ranging from 2.0 to 4.0wt%, preferably 3wt%;
iv. Shorea robusta in an amount ranging from 2.0 to 4.0wt%, preferably 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 2.0 to 4.0wt%,preferably 2wt%;
vi. Azadirachta indica in an amount ranging from 0.5 to 1.5wt%, preferably 1wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.5 to 1.5wt%, preferably
1wt%;
viii. Jatyadi oil in an amount ranging from 2.0 to 5wt%, preferably 4wt%;
ix. Yashad bhasma in an amount ranging from 0.5 to 2.5wt%, preferably 1.5wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group consisting
of oils, emulsifiers, preservatives, stabilizers, humectants and water.
In another embodiment the formulation is in the form of powder; said powder comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.1 to2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of diluents and fragrances.
In still another embodiment the formulation is in the form of a gel, said gel comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;

iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.25 to2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of gelling agents, humectants, stabilizers, preservatives and water.
In yet another embodiment the formulation is in the form of an ointment, said ointment comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1 to 5.0wt%;
ix. Yashad bhasma in an amount ranging from 0.25 to2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of oils, waxes, emulsifiers, preservatives, stabilizers, humectants and water.
In further embodiment the formulation is in the form of a paste, said paste comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.25 to2wt%; and

x. at least one pharmaceutically acceptable excipient selected from the group
consisting of emulsifiers, humectants, preservatives, stabilizers and water.
In accordance with still another embodiment of the present disclosure the formulation is in the form of a lotion, said lotion comprising:
i. Ficus religiosa in an amount ranging from 2.0 to 4.0wt%;
ii. Ficus bengalensis in an amount ranging from 1.0 to 3.0wt%;
iii. Centella asiatica in an amount ranging from 2.0 to 4.0wt%;
iv. Shorea robusta in an amount ranging from 2.0 to 3.0wt%;
v. Glycyrrhiza glabra in an amount ranging from 1.0 to 3.0wt%;
vi. Azadirachta indica in an amount ranging from 0.5 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.5 to 2wt%;
viii. Jatyadi oil in an amount ranging from 2.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.5 to 2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of emulsifiers, preservatives, stabilizers, humectants and water.
In accordance with another aspect of the present disclosure there are provided processes for the preparation of herbal based synergistic formulations. The inventors of the present disclosure conducted several experiments to develop a process which can provide a formulation with desired characteristics. It is found that the proportion and order of addition of active ingredients play important role. The optimized process for each dosage form is provided herein below.
In one embodiment there is provided a process for the preparation of a herbal based synergistic formulation in the form of a cream. The process involves the following steps:
In the first step, 0.5 to 10 wt% of Ficus religiosa; 0.1 to 7 wt% of Ficus bengalensis; 0.5 to 8wt% of Centella asiatica; 0.5 to 8wt% of Shorea robusta; 0.1 to 7wt% of Glycyrrhiza glabra; 0.1 to 6wt% of Azadirachta indica; 0.1 to 5wt% of Pongamia pinnata; 0.5 to 10wt% of Jatyadi oil; 0.1 to 4wt% of Yashad bhasma; and pharmaceutically acceptable excipients selected from the group consisting of oils, emulsifiers, preservatives, stabilizers, humectants and water are accurately weighed.
Water is heated at a temperature ranging from 60 to 90oC. To this hot water at least one preservative and at least one stabilizer are added with continuous stirring. Then Ficus

religiosa; Ficus bengalensis; Centella asiatica; Shorea robusta; Glycyrrhiza glabra;
Azadirachta indica and Pongamia glabra (pinnata) are incorporated with continuous stirring
to obtain a mixture. The mixture is then filtered to obtain a filtrate.
In the next step, at least one humectant is added to the filtrate with continuous stirring
followed by heating at a temperature ranging from 60 to 900C to obtain an aqueous phase.
Then Jatyadi oil; at least one oil and at least one emulsifier are heated in a separate vessel at a
temperature ranging from 60 to 900C followed by adding at least one stabilizer to obtain an
oil phase.
The obtained oil phase is then added to the aqueous phase with continuous stirring to obtain a
mass which is cooled to a temperature ranging from 30 to 500C.
Finally, Yashad bhasma is incorporated to the mass with continuous stirring to obtain a
cream.
In accordance with another embodiment there is provided a process for the preparation of a herbal based synergistic formulation in the form of an ointment. The process involves the following steps:
In the first step, 0.5 to 10 wt% of Ficus religiosa; 0.1 to 7 wt% of Ficus bengalensis; 0.5 to 8wt% of Centella asiatica; 0.5 to 8wt% of Shorea robusta; 0.1 to 7wt% of Glycyrrhiza glabra; 0.1 to 6wt% of Azadirachta indica; 0.1 to 5wt% of Pongamia glabra (pinnata); 0.5 to 10wt% of Jatyadi oil; 0.1 to 4wt% of Yashad bhasma; and pharmaceutically acceptable excipients selected from the group consisting of waxes, oils, emulsifiers, preservatives, stabilizers and water are weighed accurately.
Water is heated at a temperature ranging from 60 to 90oC. To this hot water at least one
preservative and at least one stabilizer are added with continuous stirring. Then Ficus
religiosa; Ficus bengalensis; Centella asiatica; Shorea robusta; Glycyrrhiza glabra;
Azadirachta indica and Pongamia glabra (pinnata) are incorporated with continuous stirring to obtain a mixture. The mixture is filtered to obtain an aqueous phase.
In the next step, Jatyadi oil; at least one wax; at least one oil and at least one emulsifier are heated in a separate vessel at a temperature ranging from 60 to 900C followed by adding at least one stabilizer to obtain an oil phase.
The obtained aqueous phase is added to the oil phase with continuous stirring to obtain a mass which is then cooled to a temperature ranging from 30 to 500C.

Finally, Yashad bhasma is incorporated to the mass with continuous stirring to obtain an ointment.
In accordance with another embodiment there is provided a process for the preparation of a herbal based synergistic formulation in the form of a gel. The process involves the following steps:
In the first step, 0.5 to 10 wt% of Ficus religiosa; 0.1 to 7 wt% of Ficus bengalensis; 0.5 to
8wt% of Centella asiatica; 0.5 to 8wt% of Shorea robusta; 0.1 to 7wt% of Glycyrrhiza
glabra; 0.1 to 6wt% of Azadirachta indica; 0.1 to 5wt% of Pongamia glabra (pinnata); 0.5 to
10wt% of Jatyadi oil; 0.1 to 4wt% of Yashad bhasma; and pharmaceutically acceptable
excipients selected from the group consisting of gelling agents, humectants, preservatives,
stabilizers and water are accurately weighed.
Water is heated at a temperature ranging from 40 to 70oC. To this hot water at least one
preservative, at least one humectant and at least one stabilizer are added with continuous
stirring to obtain a mixture.
Separately a blend of Ficus religiosa; Ficus bengalensis; Centella asiatica; Shorea robusta;
Glycyrrhiza glabra; Azadirachta indica; Pongamia glabra (pinnata) and at least one gelling
agent is prepared with continuous stirring.
The obtained blend is dispersed into the above mixture with continuous stirring followed by
incorporating aqueous solution of sodium hydroxide with continuous stirring to obtain a
mass. Separately, at least one stabilizer is dissolved in Jatyadi oil. This oil containing
stabilizer is added to the mass.
Finally, Yashad bhasma is incorporated to the mass with continuous stirring to obtain a gel.
The formulation of the present disclosure is used for the treatment of cuts, wounds, burns,
infections, sepsis, non-healing ulcers, for reducing scar-formation, for treating skin conditions
such as psoriasis, rashes, eczema, and having particular advantage as an antimicrobial agent,
for enhancing wound closure, for accelerating wound healing and for reducing wound pain,
inflammation and edema.
In accordance with one embodiment of the present disclosure the formulation of the present disclosure is used for accelerating wound healing cascade.

The formulation of the present disclosure is topically applied to skin in need of the reduction or elimination of wounds. As used herein "wound" or "wounds" refer to any detectable break in the tissues of the body, such as injury to skin. Such injuries can appear due to a number of factors such as, for example, physical trauma such as those caused by external forces such as motor vehicle accidents, falls and the mishandling of sharp objects, tools, machinery and weapons; environmental damage such as sunburns; and/or other diseased or dysfunctional states of the body such as diabetes. Wounds further refers to cuts and scrapes known as open wounds, as well as others, such as deep bruises, or closed wounds.
The formulation of the present disclosure is capable of treating one or more types of wounds which include but are not limited to abrasions such as those caused by scraping to the outer layer of skin; incisions such as those caused by sharp edges, knives, metal edges, broken glass or other sharp object; lacerations or jagged, irregular cuts or tears of the skin; punctures such as those caused by an object piercing the skin layers and creating a small hole.
The formulation of the present disclosure is also capable of treating wounds which include but are not limited to puncture wounds, gaping wounds, wounds having fatty layers, tissue or muscle exposed, wounds having one or more foreign bodies therein, wounds causing severe pain, wounds having blood flowing there from, or any wound that causes numbness or loss of movement below the wound.
The formulation of the present disclosure is effectively be used for treating the conditions/diseases/disorders of human, animals, reptiles, mammals, and birds.
Other non-limiting examples of wounds which is treated by using the formulation of the present disclosure includes animal bites, bee stings, insect bites, skin tears or lacerations, surgical incisions, including slow or non-healing surgical wounds, ulcers, including diabetic foot ulcers, pressure ulcers, traumatic ulcers, and skin diseases and cellulitis such.
In accordance with another aspect of the present disclosure there is provided a process for the preparation of a medicinal formulation.
In accordance with another aspect of the present disclosure there is provided a method of treating at least one disorder/disease/condition selected from the group consisting of wound, cuts, burns, inflammation, infections, and skin condition/disease/disorder.

The method of treating consists of topically administering to a subject in need thereof an effective amount of the medicinal formulation of the present disclosure.
The formulation of the present disclosure shows synergistic effect in treating wound. It is known that Polyphenols play an important role in wound healing. Plant extracts such as Ficus religiosa, Ficus benghalensis, Centella asiatica, Shorea robusta, Glycyrrhiza glabra, Azadirachta indica, Pongamia pinnata and Jatyadi oil also contain polyphenols as gallic acid. This polyphenol is mainly effective in the treatment of wound. Previously published scientific literature describes the anti-fungal and anti-viral properties of gallic acid (polyphenol). Further, gallic acid (polyphenol) also acts as an antioxidant and helps to protect cells against oxidative damage. Also, gallic acid (polyphenol) was found to show cytotoxicity against cancer cells, without harming healthy cells and used as a remote astringent in cases of internal hemorrhage.
In accordance with the present disclosure, the total amount (percent) of polyphenol (as gallic acid) present in the 100gm of formulation (cream) of the present disclosure was determined. Further, the percentage of polyphenol as a gallic acid present in each plant extract employed in the present formulation was determined.
Table 1: Determination of Polyphenol content

Sr. No Name of Sample Botanical Name Polyphenol
as Gallic acid
(per 100gm of cream)
1 Yastimadhu Extract Glycyrrhiza glabra extract 0.16
2 Mandukparni Extract Centella asiatica extract 0.16
3 Karanj Extract Pongamia pinnata extract 0.06
4 Neem Extract Azadirachta indica extract 0.05
5 Nyagrodha Extract Ficus bengalensis extract 0.25
6 Ashwatha Extract Ficus religiosa extract 0.40
7 Shala Extract Shorea robusta extract 0.34
8 Jatyadi Oil Classical Formulation 0.0028
Total=1.4228
9 Wound Healing Cream of the present disclosure (Example 8-F-4 ) Cream Formulation 10.71

From the study, it is surprisingly observed that the weight percentage of polyphenol (as gallic acid) per 100gm of formulation of the present disclosure is significantly higher than the sum total of the weight percentage of the polyphenol (as gallic acid) content of the ingredients (1-8) of the formulation.
The sum total of the percentage of polyphenols as gallic acid of various constituents is 1.4228 wt. %, whereas the percentage of polyphenol as gallic acid in the formulation of the present disclosure is found to be 10.71 wt.% per 100 gm of formulation. Thus, the polyphenol (as gallic acid) content of the present formulation is ~eight times greater than the sum total of weight percentage of polyphenol as gallic acid content of each constituent (1-8).
It is envisaged that the presence of polyphenol as gallic acid content in significantly high % in the present formulation can be responsible for enhanced wound healing activity. The presence of polyphenol as gallic acid content in significantly high % in the present formulation may be attributed to solubilisation of more polyphenols due to interaction with other active ingredients and excipients of formulation when used in a specific proportion.
The present disclosure is further illustrated herein below with the help of the following examples. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

Example 1
A formulation in the form of a cream was prepared using the following ingredients:
Table 2: Cream Formulation (F-1)

Sr. No Ingredients Quantity % w/w
1. Ficus religiosa extract 1.00
2. Ficus bengalensis extract 0.50
3. Centella asiatica extract 1.00
4. Shorea robusta extract 1.00
5. Glycyrrhiza glabra extract 0.50
6. Azadirachta indica extract 0.30
7. Pongamia glabra (pinnata) extract 0.30
8. Yashad Bhasma 0.40
9. Glycerin 1.00
10. Methylparaben Sodium 0.20
11. Propylparaben Sodium 0.10
12. DM water Q.S.
13. Jatyadi Taila 1.50
14. Stearic acid 13.50
15. Cetostearyl Alcohol 1.00
16. Glyceryl Monostearate 6.50
17. Light liquid paraffin 5.50
Gross Total 100
Process
1. All the ingredients were accurately weighed.
2. Ingredient No. 12 (water) was heated to 800C.
3. Ingredient Nos. 10-11 were added in preheated DM water of step 2 with continuous stirring until they dissolve completely.
4. Ingredient Nos. 1-7 were added in the solution of step 3 with continuous stirring, stirred for 10 min after addition of all the 1-7 ingredients.
5. The formed mixture of step No. 4 was filtered through nylon cloth of 100 mesh size.
6. Ingredient No.9 was then added to the filtrate of step 5 with continuous stirring and heated the mixture to 800C.
7. Product of step 6 was aqueous phase.
8. Ingredients Nos. 13-17 were taken in a separate vessel and heated to melt and attain temperature of 800C.
9. Product of step 8 was oil phase.

10. Oil phase of step 9 was slowly added to the water phase of step 7 with continuous stirring.
11. The mixture of step 10 was allowed to cool under continuous stirring.
12. Ingredient No. 8 was then added to mixture of step 11 when it attained the temperature of 500C.
13. The mixture was then continued to cool by stirring to attain room temperature.
Example 2:
A formulation in the form of a cream was prepared using the following ingredients:
Table 3: Cream Formulation (F-2)

Sr. No. Ingredients % w/w
1. Ficus religiosa extract 1.50
2. Ficus bengalensis extract 1.00
3. Centella asiatica extract 1.50
4. Shorea robusta extract 1.50
5. Glycyrrhiza glabra extract 1.00
6. Azadirachta indica extract 0.60
7. Pongamia glabra (pinnata) extract 0.60
8. Yashad Bhasma 0.80
9. Glycerin 1.00
10. Methylparaben Sodium 0.20
11. Propylparaben Sodium 0.10
12. DM water Q.S.
13. Jatyadi Taila 2.00
14. Stearic acid 13.00
15. Cetostearyl Alcohol 1.00
16. Glyceryl Monostearate 6.50
17. Light liquid paraffin 5.50
Gross Total 100

Process: The formulation was prepared using the process provided in example 1. Example 3:
A formulation in the form of a cream was prepared using the following ingredients:
Table 4: Cream Formulation (F-3)

Sr. No. Ingredients % w/w
1. Ficus religiosa extract 2.50
2. Ficus bengalensis extract 1.50
3. Centella asiatica extract 2.50
4. Shorea robusta extract 2.50
5. Glycyrrhiza glabra extract 1.50
6. Azadirachta indica extract 0.75
7. Pongamia glabra (pinnata) extract 0.75
8. Yashad Bhasma 1.25
9. Glycerin 1.00
10. Methylparaben Sodium 0.20
11. Propylparaben Sodium 0.10
12. DM water Q.S.
13. Jatyadi Taila 3.00
14. Stearic acid 12.5
15. Cetostearyl Alcohol 1.00
16. Glyceryl Monostearate 6.25
17. Light liquid paraffin 5.20
Gross Total 100
Process: The formulation was prepared using the process provided in example 1. Example 4:
A formulation in the form of a cream was prepared using the following ingredients:

Table 5: Cream Formulation (F-5)

Sr. No. Ingredients Quantity % w/w
1 Ficus religiosa extract 4.00
2 Ficus bengalensis extract 3.50
3 Centella asiatica extract 4.00
4 Shorea robusta extract 4.00
5 Glycyrrhiza glabra extract 3.50
6 Azadirachta indica extract 2.00
7 Pongamia glabra (pinnata) extract 2.00
8 Yashad Bhasma 2.00
9 Glycerin 1.00
10 Methylparaben Sodium 0.20
11 Propylparaben Sodium 0.10
12 DM water Q.S.
13 Jatyadi Taila 5.00
14 Stearic acid 7.00
15 Cetostearyl Alcohol 1.00
16 Glyceryl Monostearate 2.50
17 Light liquid paraffin 0.00
Gross Total 100
Process: The formulation was prepared using the process provided in example 1.

Example 5:
A formulation in the form of a cream was prepared using the following ingredients:
Table 6: Cream Formulation (F-6)

Sr. No. Ingredients Quantity % w/w
1 Ficus religiosa extract 4.50
2 Ficus bengalensis extract 3.50
3 Centella asiatica extract 4.50
4 Shorea robusta extract 4.00
5 Glycyrrhiza glabra extract 3.50
6 Azadirachta indica extract 2.50
7 Pongamia glabra (pinnata) extract 2.00
8 Yashad Bhasma 2.00
9 Glycerin 1.00
10 Methylparaben Sodium 0.20
11 Propylparaben Sodium 0.10
12 DM water Q.S.
13 Jatyadi Taila 6.00
14 Stearic acid 4.00
15 Cetostearyl Alcohol 1.00
16 Glyceryl Monostearate 2.00
17 Light liquid paraffin 0.00
Gross Total 100
Process: The formulation was prepared using the process provided in example 1. Example 6:
A formulation in the form of a cream was prepared using the following ingredients:

Table 7: Cream Formulation (F-7)

Sr. No Ingredients Quantity % w/w
1 Ficus religiosa extract 5.00
2 Ficus bengalensis extract 3.50
3 Centella asiatica extract 5.00
4 Shorea robusta extract 4.00
5 Glycyrrhiza glabra extract 3.50
6 Azadirachta indica extract 3.00
7 Pongamia glabra (pinnata) extract 2.00
8 Yashad Bhasma 2.00
9 Glycerin 1.00
10 Methylparaben Sodium 0.20
11 Propylparaben Sodium 0.10
12 DM water Q.S.
13 Jatyadi Taila 7.00
14 Stearic acid 6.00
15 Cetostearyl Alcohol 0.70
16 Glyceryl Monostearate 3.00
17 Light liquid paraffin 0.00
Gross Total 100
Process: The formulation was prepared using the process provided in example 1.
Example 7:
Placebo [Control /Base of formulation]

Table 8: Cream Formulation Placebo

Sr. No. Ingredients % w/w
1 Ficus religiosa extract 0.00
2 Ficus bengalensis extract 0.00
3 Centella asiatica extract 0.00
4 Shorea robusta extract 0.00
5 Glycyrrhiza glabra extract 0.00
6 Azadirachta indica extract 0.00
7 Pongamia glabra (pinnata) extract 0.00
8 Yashad Bhasma 0.00
9 Glycerin 5.00
10 Methylparaben Sodium 0.20
11 Propylparaben Sodium 0.10
12 DM water Q.S.
13 Jatyadi Taila 0.00
14 Stearic acid 9.00
15 Cetostearyl Alcohol 1.00
16 Glyceryl Monostearate 4.00
17 Light liquid paraffin 3.00
Gross Total 100
Process: The formulation was prepared using the process provided in example 1.
Example 8:
A formulation in the form of a cream was prepared using the following ingredients:

Table 9: Cream Formulation (F-4)

Sr. no. Ingredient %w/w
1 Ficus religiosa extract 3.00
2 Ficus bengalensis extract 2.00
3 Centella asiatica extract 3.00
4 Shorea robusta extract 3.00
5 Glycyrrhiza glabra extract 2.00
6 Azadirachta indica extract 1.00
7 Pongamia glabra (pinnata) extract 1.00
8 Methylparaben sodium 0.20
9 Propylparaben sodium 0.10
10 Disodium edetate 0.10
11 Propyl gallate 0.20
12 DM water Q.S.
13 Glycerin 5.00
14 Yashad bhasma 1.50
15 Jatyadi taila 4.00
16 Stearic acid 6.00
17 Cetostearyl alcohol 1.00
18 Glyceryl monostearate 3.00
19 Light liquid paraffin 8.00
20 Butylated hydroxyanisole 0.02
21 Butylated hydroxytoluene 0.10
Gross Total 100
Process
1. All the ingredients were accurately weighed.
2. Ingredient No. 12 (water) was heated to 800C.
3. Ingredient Nos. 8-11 were added into preheated DM water of step 2 with continuous stirring until they dissolve completely.
4. Ingredient Nos. 1-7 was added in solution of step 3 with continuous stirring. The mixture was stirred for 10 min after addition of all the 1-7 ingredients.
5. The formed mixture of step No. 4 was filtered through nylon cloth of 100 mesh size.

6. Ingredient No.13 was added to the filtrate of step 5 with continuous stirring and heated the mixture to 800C.
7. Product of step 6 was aqueous phase.
8. Ingredients Nos. 15-19 were taken in a separate vessel and heated to melt and attain the temperature of 800C.
9. Ingredient Nos. 20-21were dissolved in hot clear oil phase of step 8.
10. Product of step 9 was oil phase.
11. Oil phase of step 10 was slowly added to the water phase of step 7 with continuous stirring.
12. The mixture of step 11 was allowed to cool under continuous stirring.
13. Ingredient No. 14 was added to the mixture of step 12 when it attains temperature of 500C.
14. The stirring was continued until the mixture attains room temperature.
Example 9:
A formulation in the form of an ointment was prepared using the following ingredients:
Table 10: Ointment Formulation

Sr. No. Ingredient %w/w
1. Ficus religiosa extract 1.50
2. Ficus bengalensis extract 1.00
3. Centella asiatica extract 1.50
4. Shorea robusta extract 1.50
5. Glycyrrhiza glabra extract 1.00
6. Azadirachta indica extract 0.50
7. Pongamia glabra (pinnata) extract 0.50
8. Methylparaben sodium 0.20
9. Propylparaben sodium 0.10
10. Disodium edetate 0.10
11. Propyl gallate 0.20
12. DM water Q.S.
13. Yashad bhasma 0.75
14. Jatyadi taila 4.00
15. Cetostearyl alcohol 5.00
16. Hard paraffin 7.00
17. Soft paraffin 60.00
18. Butylated hydroxyanisole 0.02
19. Butylated hydroxytoluene 0.10
Gross Total 100

Process
1. The ingredients were accurately weighed.
2. Ingredient No. 12 (water) was heated to 800C.
3. Ingredient Nos. 8-11 were added into preheated DM water of step 2 with continuous stirring until they dissolved completely.
4. Ingredient Nos. 1-7 were then added in the solution of step 3 with continuous stirring. The formed mixture was stirred for 10 min.
5. The formed mixture of step No. 4 was filtered through nylon cloth of 100 mesh size.
6. Product of step 5 was aqueous phase.
7. Ingredient Nos. 14-17 were taken in separate vessel and heated to melt and attain the temperature of 800C.
8. Ingredient Nos. 18-19 were dissolved into hot clear oil phase of step 7.
9. Product of step 8 was oil phase.
10. Water phase of step 6 was slowly added to the oil phase of step 9 with continuous stirring.
11. The mixture of step 10 was allowed to cool under continuous stirring.
12. Ingredient No. 13 was then added to the mixture of step 11 when it attains 50oC.
13. The mixture was stirred continuously to attain room temperature.
Example 10:
A formulation in the form of a Paste was prepared using the following ingredients:

Table 11: Paste Formulation

Sr. No. Ingredient %w/w
1. Ficus religiosa extract 1.50
2. Ficus bengalensis extract 1.00
3. Centella asiatica extract 1.50
4. Shorea robusta extract 1.50
5. Glycyrrhiza glabra extract 1.00
6. Azadirachta indica extract 0.50
7. Pongamia glabra (pinnata) extract 0.50
8. Methylparaben sodium 0.10
9. Propylparaben sodium 0.05
10. Disodium edetate 0.05
11. Sodium Sulphite anhydrous 0.10
12. DM water Q.S.
13. Glycerin 2.00
14. Yashad bhasma 0.75
15. Calcium carbonate 50.00
16. Jatyadi taila 2.00
17. Stearic acid 2.00
18. Cetostearyl alcohol 0.50
19. Glyceryl monostearate 1.00
20. Light liquid paraffin 3.50
21. Butylated hydroxyanisole 0.01
22. Butylated hydroxytoluene 0.05
TOTAL WEIGHT 100
Process
1. All the ingredients were accurately weighed.
2. Ingredient No. 12 (water) was heated to temperature 800C.
3. Ingredient Nos. 8-11 were then added into preheated DM water of step 2 with continuous stirring until they dissolve completely.
4. Ingredient Nos. 1-7 were added in solution of step 3 with continuous stirring. The mixture was stirred for 10 min after the addition of all the 1-7 ingredients.
5. The formed mixture of step No. 4 was filtered through nylon cloth of 100 mesh size.
6. Ingredient No. 13 was then added to the mixture of step 5 with continuous stirring and heated the mixture to 800C temperature.
7. Product of step 6 was aqueous phase.
8. Ingredient Nos. 16-20 were taken in separate vessel and heated to melt and attain the temperature 800C.
9. Ingredient Nos. 21-22 were dissolved into hot clear oil phase of step 8.

10. Product of step 9 was oil phase.
11. Oil phase of step 10 was slowly added to water phase of step 7 with continuous stirring.
12. The mixture of step 11 was allowed to cool under continuous stirring.
13. Ingredient No. 14 was then added to the mixture of step 12 when it attains temperature of 500C.
14. The mixture was continually stirred to attain room temperature
15. Ingredient No. 15 was added to the product step of 14 and mixed.
Example 11:
A formulation in the form of powder was prepared using the following ingredients:
Table 12: Powder Formulation

Sr. No. Ingredient %w/w
1. Ficus religiosa extract 1.50
2. Ficus bengalensis extract 1.00
3. Centella asiatica extract 1.50
4. Shorea robusta extract 1.50
5. Glycyrrhiza glabra extract 1.00
6. Azadiracta indica extract 0.50
7. Pongamia glabra (pinnata) extract 0.50
8. Yashad Bhasma 0.50
9. Jatyadi Taila 2.00
10. Maize Starch 20.00
11. Talc 70.00
12. Fragrance channel 5 Q.S.
Total Weight 100
Process
1. All the ingredients were accurately weighed.
2. Ingredient No.9 was mixed with ingredient No.11 by geometrical mixing.
3. Ingredient No. 12 was mixed with ingredient No.10 by geometrical mixing.
4. Ingredient Nos. 1-8 were mixed uniformly.
5. The blends of steps 2-4 were mixed together.
6. The blend of step 5 was sifted through 60# sieve.
Example 12:
A formulation in the form of a lotion was prepared using the following ingredients:

Table 13: Lotion Formulation

Sr. No. Ingredient %w/w
1. Ficus religiosa extract 3.00
2. Ficus bengalensis extract 2.00
3. Centella asiatica extract 3.00
4. Shorea robusta extract 3.00
5. Glycyrrhiza glabra extract 2.00
6. Azadiracta indica extract 1.00
7. Pongamia glabra (pinnata) extract 1.00
8. Methylparaben sodium 0.20
9. Propylparaben sodium 0.10
10. Disodium edetate 0.10
11. Propyl gallate 0.20
12. DM water Q.S.
13. Glycerin 5.00
14. Yashad bhasma 1.50
15. Jatyadi taila 4.00
16. Stearic acid 4.00
17. Cetostearyl alcohol 0.75
18. Glyceryl monostearate 2.50
19. Light liquid paraffin 5.00
20. Butylated hydroxyanisole 0.02
21. Butylated hydroxytoluene 0.10
Total Weight 100
Process
1. All the ingredients were accurately weighed.
2. Ingredient No. 12 was heated to 800C.
3. Ingredient Nos. 8-11 were added into preheated DM water of step 2 with continuous stirring until they dissolve completely.
4. Ingredient Nos. 1-7 were added in solution of step 3 with continuous stirring, stirred the mixture for 10 min after addition of all the 1-7 ingredients.
5. The formed mixture of step No. 4 was filtered through nylon cloth of 100 mesh size.
6. Ingredient No.13 was added to the filtrate of step 5 with continuous stirring and the mixture was heated to 800C.
7. Product of step 6 was aqueous phase.
8. Ingredients Nos. 15-19 were taken in a separate vessel and heated to melt and attained temperature 800C.
9. Ingredient No. 20-21 were dissolved in hot clear oil phase of step 8.
10. Product of step 9 was oil phase.

11. Then oil phase of step 10 was slowly added to the water phase of step 7 with continuous stirring.
12. The mixture of step 11was allowed to cool under continuous stirring.
13. Ingredient No. 14 was added to the mixture of step 12 when it attain 500C.
14. The mixture was continuously stirred to attain room temperature.
Example 13
A formulation in the form of a gel was prepared using the following ingredients:
Table 14: Gel Formulation

Sr. No. Ingredient %w/w
1. Ficus religiosa extract 1.50
2. Ficus bengalensis extract 1.00
3. Centella asiatica extract 1.50
4. Shorea robusta extract 1.50
5. Glycyrrhiza glabra extract 1.00
6. Azadiracta indica extract 0.50
7. Pongamia glabra (pinnata) extract 0.50
8. Acrypol 934 4.00
9. Propylparaben Sodium 0.10
10. Methylparaben Sodium 0.20
11. Sodium hydroxide (20% solution) 2.00
12. DM water Q.S.
13. Glycerin 5.00
14. Yashad bhasma 0.75
15. Jatyadi taila 2.00
16. Butylated hydroxyanisole 0.02
17. Butylated hydroxytoluene 0.10
Total Weight 100
Process
1. All the ingredients were accurately weighed.
2. Ingredient Nos.1-8 were mixed uniformly and shifted through sieve No. 40.
3. Ingredient No. 12 was heated to 500C separately.
4. Ingredient Nos. 9, 10 and 13 were mixed and dissolved in ingredient No. 12 (water).
5. Blend of step 2 was dispersed into preheated DM water of step 4 with continuous stirring.

6. Ingredient No. 11 was slowly added in the solution of step 5 with continuous stirring until it turns into a gel.
7. Further, ingredient Nos. 16-17 were dissolved into ingredient No.15.
8. The oily solution of step 7 was mixed with the product of step 6 with continuous stirring.
9. The ingredient No. 14 was mixed uniformly with product of step 8.
PRE-CLINICAL STUDY:
A comparative efficacy study of the present formulation and Jatyadi oil was carried out in Wistar Albino rats using excision and incision animal wound models.
Excision wound model:
The animals were acclimatized for 5 days and maintained at 25± 20C and relative humidity of 45 to 55% and under standard environmental conditions (12 h light and 12 h dark cycle). The food and water were provided ad libitum.
Rats were anaesthetized with ketamine I.P. (50-60 mg/kg) and xylazinc I.P. (5-10 mg/kg). Animals were shaved on a right side. The area of the wound was outlined with methylene blue using circular stencil. A full thickness excision wound of around 300mm2and 2 mm in depth was created to each animal. The entire wound was left open. Treatments were given to respective group as per study design. Treatments were given topically twice a day. Wound area measurement on day 1, 3, 7, 11 and 15 were recorded. Wound area was traced using transparency and permanent marker. Recording of the wound area was carried out using a graph paper. Photographs for day 1, 9 and 13 were taken. Day of complete epithelialization was recorded for each animal. Skin samples of animals were collected and histopathological studies were performed considering epithelialization, neoangiogenesis, neutrophil infiltration, collagen deposition and the like as wound healing parameters.
Incision wound model:
Rats were anaesthetized with ketamine I.P. (50-60 mg/kg) and Xylazine I.P. (5-10 mg/kg) Animals were shaved on right side. Paravertebral straight incision of 6 cm length was made through the entire thickness of the skin. The wound was closed by means of interrupted sutures placed at approximately 1 cm apart. The treatment was done topically twice daily.

The wound breaking strength was estimated on the 10th day. The wound breaking strength was evaluated by constant water flow technique. Each anesthetized animals was secured to the operation table and a line was drawn on either side of the wound, 3 mm away from the line. Two allice forceps were firmly applied to the line facing each other. One of the forceps was fixed while the other was connected to a freely suspended light weight polypropylene graduated container through a string run over to a pulley. Water was allowed to flow from the reservoir slowly and steadily into the container. A gradual increase in weight was transmitted to the wound site pulling apart the wound edges. As and when just opened up, the water flow was arrested and the volume of water collected in the container was noted. The average reading of the group was taken as an individual value of breaking strength.
Table 15- Study Design

Gr. No. Group Description No. of Animals (N)
I Normal Control (Base of formulation) 6
II Formulation No.1 (F-1) 6
III Formulation No.2 (F-2) 6
IV Formulation No.3 (F-3) 6
V Formulation No.4 (F-4) 6
VI Formulation No.5 (F-5) 6
VII Formulation No.6 (F-6) 6
VIII Formulation No.7 (F-7) 6
IX Positive control (Mupirocin) 6
X Jatyadi Oil Formulation 6
The results obtained from the incision and excision wound models are expressed as mean +SEM. Statistical significance was checked by applying ANOVA test followed by posttest at p<0.05 and p<0.01.
The results are shown in tables16 and 17.
Table 16: Effect of topical application of various formulations of the present disclosure, Mupirocin cream (Positive control) and Jatyadi oil on days required for epithelialization in excision model.

Treatment Days of epithelialization (Mean ± SEM)
Placebo 27 ±1
F-1 26 ± 1
F-2 18±1**
F-3 17± 1***
F-4 15±0***
F-5 25 ± 2
F-6 19±2*
F-7 16±1***
Mupirocin 18± 2**
Jatyadi Oil 23 ± 2#
* P<0.05 ** P<0.01 *** P<0.001 significant as compared to using one-way ANOVA followed Bonferroni posttest. # P<0.05 Significant as compared to Formulation-4 using one-way ANOVA followed by Bonferroni post lest
Table 17: Effect of topical application of various formulations of the present disclosure, Mupirocin cream (Positive control) and Jatyadi oil on wound breaking strength (Incision wound model)

Treatment Wound breaking Strength (Mean ± SEM)
Placebo 309.17 ± 19.85
F-1 256.67 ± 12.02
F-2 253.33 ± 8.43
F-3 296.67 ± 18.56
F-4 388.00 ± 46.38**
F-5 278.33 ± 46.76
F-6 310.00 ± 30.22
F-7 250.00 ± 19.66
Mupirocin 248.33 ± 19.56
Jatyadi Oil 313.33 ± 19.78

** P<0.01 significant as compared to Mupirocin using one-way ANOVA followed by Bonferroni posttest.
Histopathological study
In histological analysis it was observed that the wounds of rats from control group are not fully restored and there is presence of inflammatory cells in scar tissue. Re-epithelialization of the wounds was incomplete.
As compared to positive control (Mupirocin), the present formulation (F-4) showed complete epithelialization, more blood vessels and more collagen fibers.
Microscopic observations of the wounds of animals treated with formulation F-4 showed complete re-epithelialization and a normal epidermis covering the wound area. Collagen fibers were thick and denser as compared to placebo, control and Jatyadi oil. The cutaneous annexes, such as sebaceous glands and hair follicles in the center of the scar tissue were also well formed. This indicated that the formulation no.4 stimulates and accelerates the activities towards faster wound healing and play a role in the early stage of the wound healing process as compared with control and positive control group.
The results indicate there is a significant decrease in days required for complete epithelialization when the present formulation (F-4) is used as compared to placebo control. Further, in incision wound model, there is statistically significant increase in the tensile strength of wounds in the Formulation No. 4 (F-4) treated animals as compared to placebo control and this may be due to the increase in collagen concentration and stabilization of the fibers as also observed in the histopathological studies. It is envisaged the observed increase in tensile strength is not only due to increased collagen synthesis but also due to its proper deposition and alignment.
The present formulations (F-2, F-3, F-4, F-6 and F-7) showed statistically significant decrease in days required for complete re-epithelialization as compared to placebo in excision model. This activity in formulation nos. 2, 3, 4 and 7 is even better than the Jatyadi oil formulation. Moreover, formulation No. 4 showed statistically significant increase in tensile strength of incision wound as compared to the placebo control group. Formulation no.

4 also showed complete epithelialization and good collagen deposition as compared to Placebo cream and Jatyadi Oil.
The study illustrates the importance of proportion of each ingredient in the formulation. From the results, it can be concluded that mere mixing of all herbal ingredients, Jatyadi oil and Yashad Bhasma is not sufficient to achieve the desired enhanced efficacy (wound healing activity). Thus, in order to achieve the synergistic effect, it is desired to mix the active ingredients in specific proportions. The formulation (F-4) of the present disclosure shows synergistic effect.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the present disclosure to achieve one or more of the desired objects or results.
The numerical values given for various physical parameters, dimensions and quantities are only approximate values and it is envisaged that the values higher than the numerical value assigned to the physical parameters, dimensions and quantities fall within the scope of the present disclosure, unless there is a statement in the specification to the contrary.
While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Variations or modifications in the process or compound or formulation or combination of this invention, within the scope of the invention, may occur to those skilled in the art upon reviewing the disclosure herein. Such variations or modifications are well within the spirit of the present disclosure.

WE CLAIM:
1. A herbal based synergistic formulation comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 10wt%;
ii. Ficus bengalensis in an amount ranging from 0.1 to 7wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 8wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 8wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.1 to 7wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 6wt%;
vii. Pongamia pinnata in an amount ranging from 0.1 to 5wt%;
viii. Jatyadi oil in an amount ranging from 0.5 to 10wt%;
ix. Yashad bhasma in an amount ranging from 0.1 to 4wt%; and
x. at least one pharmaceutically acceptable excipient.
2. The formulation as claimed in claim 1, wherein said formulation is in a dosage form selected from the group consisting of a cream, a lotion, a gel, powder, a paste and an ointment.
3. The formulation as claimed in claim 1, wherein said excipient is selected from the group consisting of solvents, surfactants, wetting agents, humectants, fragrances, emulsifiers, oils, waxes, stabilizers, lubricants, preservatives, gelling agents, diluents and combinations thereof.
4. The formulation as claimed in claim 1, wherein Ficus religiosa, Ficus bengalensis, Centella asiatica, Shorea robusta, Glycyrrhiza glabra Azadirachta indica and Pongamia glabra (pinnata) are in the form of extract, said extract being selected from the group consisting of alcoholic extract, aqueous extract and hydro-alcoholic extract.
5. The formulation as claimed in claim 1, wherein said formulation is in the form of a
cream, said cream comprising:
i. Ficus religiosa in an amount ranging from 2.0 to 4.0wt%, preferably 3wt%;
ii. Ficus bengalensis in an amount ranging from 1.0 to 3.0wt%, preferably 2wt%;
iii. Centella asiatica in an amount ranging from 2.0 to 4.0wt%, preferably 3wt%;
iv. Shorea robusta in an amount ranging from 2.0 to 4.0wt%, preferably 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 2.0 to 4.0wt%,preferably 2wt%;
vi. Azadirachta indica in an amount ranging from 0.5 to 1.5wt%, preferably 1wt%;

vii. Pongamia glabra (pinnata) in an amount ranging from 0.5 to 1.5wt%, preferably
1wt%;
viii. Jatyadi oil in an amount ranging from 2.0 to 5wt%, preferably 4wt%;
ix. Yashad bhasma in an amount ranging from 0.5 to 2.5wt%, preferably 1.5wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group consisting
of oils, emulsifiers, preservatives, stabilizers, humectants and water.
6. The formulation as claimed in claim 1, wherein said formulation is in the form of
powder; said powder comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.1 to2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of diluents and fragrances.
7. The formulation as claimed in claim 1, wherein said formulation is in the form of a
gel, said gel comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.25 to2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of gelling agents, humectants, stabilizers, preservatives and water.

8. The formulation as claimed in claim 1, wherein said formulation is in the form of an
ointment, said ointment comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1 to 5.0wt%;
ix. Yashad bhasma in an amount ranging from 0.25 to2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of oils, waxes, emulsifiers, preservatives, stabilizers, humectants and water.
9. The formulation as claimed in claim 1, wherein said formulation is in the form of a
paste, said paste comprising:
i. Ficus religiosa in an amount ranging from 0.5 to 4wt%;
ii. Ficus bengalensis in an amount ranging from 0.5 to 3wt%;
iii. Centella asiatica in an amount ranging from 0.5 to 4wt%;
iv. Shorea robusta in an amount ranging from 0.5 to 3wt%;
v. Glycyrrhiza glabra in an amount ranging from 0.5 to 3wt%;
vi. Azadirachta indica in an amount ranging from 0.1 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.1 to 2wt%;
viii. Jatyadi oil in an amount ranging from 1.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.25 to2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of diluents, emulsifiers, humectants, preservatives, stabilizers and water.
10. The formulation as claimed in claim 1, wherein said formulation is in the form of a
lotion, said lotion comprising:
i. Ficus religiosa in an amount ranging from 2.0 to 4.0wt%;
ii. Ficus bengalensis in an amount ranging from 1.0 to 3.0wt%;
iii. Centella asiatica in an amount ranging from 2.0 to 4.0wt%;
iv. Shorea robusta in an amount ranging from 2.0 to 3.0wt%;

v. Glycyrrhiza glabra in an amount ranging from 1.0 to 3.0wt%;
vi. Azadirachta indica in an amount ranging from 0.5 to 2wt%;
vii. Pongamia glabra (pinnata) in an amount ranging from 0.5 to 2wt%;
viii. Jatyadi oil in an amount ranging from 2.0 to 4wt%;
ix. Yashad bhasma in an amount ranging from 0.5 to 2wt%; and
x. at least one pharmaceutically acceptable excipient selected from the group
consisting of emulsifiers, preservatives, stabilizers, humectants and water.
11. A process for the preparation of a herbal based synergistic formulation in the form of a cream; said process comprising the following steps:
- weighing accurately 0.5 to 10 wt% of Ficus religiosa; 0.1 to 7 wt% of Ficus bengalensis; 0.5 to 8wt% of Centella asiatica; 0.5 to 8wt% of Shorea robusta; 0.1 to 7wt% of Glycyrrhiza glabra; 0.1 to 6wt% of Azadirachta indica; 0.1 to 5wt% of Pongamia glabra (pinnata); 0.5 to 10wt% of Jatyadi oil; 0.1 to 4wt% of Yashad bhasma; and pharmaceutically acceptable excipients selected from the group consisting of oils, emulsifiers, preservatives, stabilizers, humectants and water;
- heating water at a temperature ranging from 60 to 90oC;
- adding at least one preservative and at least one stabilizer in said hot water with continuous stirring;
- incorporating Ficus religiosa; Ficus bengalensis; Centella asiatica; Shorea robusta; Glycyrrhiza glabra; Azadirachta indica and Pongamia glabra (pinnata) with continuous stirring to obtain a mixture;
- filtering said mixture to obtain a filtrate;
- adding at least one humectant to said filtrate with continuous stirring followed by heating at a temperature ranging from 60 to 900C to obtain an aqueous phase;
- heating Jatyadi oil; at least one oil and at least one emulsifier in a separate vessel at a temperature ranging from 60 to 900C followed by adding at least one stabilizer to obtain an oil phase;
- adding said oil phase to said aqueous phase with continuous stirring to obtain a mass;
- cooling said mass to a temperature ranging from 30 to 500C; and
- incorporating Yashad bhasma to said mass with continuous stirring to obtain a cream.

12. A process for the preparation of a herbal based synergistic formulation in the form of an
ointment; said process comprising the following steps:
- weighing accurately 0.5 to 10 wt% of Ficus religiosa; 0.1 to 7 wt% of Ficus bengalensis; 0.5 to 8wt% of Centella asiatica; 0.5 to 8wt% of Shorea robusta; 0.1 to 7wt% of Glycyrrhiza glabra; 0.1 to 6wt% of Azadirachta indica; 0.1 to 5wt% of Pongamia glabra (pinnata); 0.5 to 10wt% of Jatyadi oil; 0.1 to 4wt% of Yashad bhasma; and pharmaceutically acceptable excipients selected from the group consisting of waxes, oils, emulsifiers, preservatives, stabilizers and water;
- heating water at a temperature ranging from 60 to 90oC;
- adding at least one preservative and at least one stabilizer in said hot water with continuous stirring;
- incorporating Ficus religiosa; Ficus bengalensis; Centella asiatica; Shorea robusta; Glycyrrhiza glabra; Azadirachta indica and Pongamia glabra (pinnata) with continuous stirring to obtain a mixture;
- filtering said mixture to obtain an aqueous phase;
- heating Jatyadi oil; at least one wax; at least one oil and at least one emulsifier in a separate vessel at a temperature ranging from 60 to 900C followed by adding at least one stabilizer to obtain an oil phase;
- adding said aqueous phase to said oil phase with continuous stirring to obtain a mass;
- cooling said mass to a temperature ranging from 30 to 500C; and
incorporating Yashad bhasma to said mass with continuous stirring to obtain an ointment.
13. A process for the preparation of a herbal based synergistic formulation in the form of a
gel; said process comprising the following steps:
- weighing accurately 0.5 to 10 wt% of Ficus religiosa; 0.1 to 7 wt% of Ficus bengalensis; 0.5 to 8wt% of Centella asiatica; 0.5 to 8wt% of Shorea robusta; 0.1 to 7wt% of Glycyrrhiza glabra; 0.1 to 6wt% of Azadirachta indica; 0.1 to 5wt% of Pongamia glabra (pinnata); 0.5 to 10wt% of Jatyadi oil; 0.1 to 4wt% of Yashad bhasma; and pharmaceutically acceptable excipients selected from the group consisting of gelling agents, humectants, preservatives, stabilizers and water;
- heating water at a temperature ranging from 40 to 70oC;

adding at least one preservative, at least one humectant and at least one stabilizer in said
hot water with continuous stirring to obtain a mixture;
mixing Ficus religiosa; Ficus bengalensis; Centella asiatica; Shorea robusta;
Glycyrrhiza glabra; Azadirachta indica; Pongamia glabra (pinnata) and at least one
gelling agent with continuous stirring to obtain a blend;
dispersing said blend into said mixture with continuous stirring followed by incorporating
aqueous solution of sodium hydroxide with continuous stirring to obtain a mass;
dissolving at least one stabilizer in Jatyadi oil;
adding said oil containing stabilizer to said mass; and
incorporating Yashad bhasma to said mass with continuous stirring to obtain a gel.