Claims:I Claim:-
1. A composition for treatment of leucoderma comprises Psoralea corylifolia extract 150-1500 gm, Emblica officinalis extract 250-1500 gm, Terminallia chebula extract 250-800 gm, Terminalia bellirica extract 250-300 gm, Piper longum extract 10-200 gm, Piper nigrum extract 10-200 gm, Plumbago zeylanica extract 10-200 gm, Picrorhiza kurroa extract 140-400 gm, Swertia chirayata extract 50-400 gm, Tinospora cordifolia extract 50-1000 gm, Cyperus rotundus extract 10-1000 gm, Cuminum cyminum extract 10-70 gm, Embelia ribes extract 100-300 gm, Asphaltum punjabianum extract 50-2000 gm, Semecarpus anacardium extract 250-1500 gm, Cinnamonum zeylanicum extract 10-150 gm, loha bhasma powder 200-1000 gm, Mesua ferrea extract 5-70 gm, Crocus sativus extract 5-150 gm, Inula recemosa extract 50-200 gm, mercury sulphate powder 150-800 gm, sulphur powder 250-1500 gm, abhrak bhasma powder 200-1800 gm, tamra bhasma powder 70-300 gm, Cimmiphora mukul extract 100-1800 gm, Acconitum ferox extract 50-800 gm, Pongamia pinnata extract 300-500 gm, Zingiber officinale extract 10-150 gm, alum powder 50-300 gm, Pterocarpus santalinus extract 250-1500 gm, dry ginger powder 10-200 gm, Peepramul powder 10-200 gm, Glycyrrhiza glabra extract 10-200 gm, Shadguna jarit extract 50-350 gm, Ocimum tenuiflorum extract 10-400 gm, Azadirachta indica extract 10-200 gm, Acorus calamus extract 20-350 gm, Trachyspermum ammi extract 10-150 gm, Centratherum anthelminticum extract 10-300 gm, Rubia cordifolia extract 10-300 gm, Nardostachys jatamansi extract 40-300 gm, Berberis aristata extract 20-300 gm, Rosa centifolia extract 50-1000 gm and copper iron sulphide powder 50-2000 gm.
2. The composition for treatment of leucoderma as claimed in claim 1, wherein administering said composition orally in the form of capsule to the patient.
Dated this 5th day of December 2017. , Description:FORM 2
THE PATENTS ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)

1. TITLE OF THE INVENTION:
'A composition for treatment of Leucoderma '

2. APPLICANT:

1. (A) Vadher Jayshree Nandlal
(B) Indian
(C) E/57, Ambica Tenaments, Opp. New Jas Park Society, Isanpur, Ahmedabad-382443,
Gujarat, India.

3. PREMABLE TO THE DESCRIPTION:
PROVISIONAL

The following specification describes the invention.
þ COMPLETE
The following specification particularly describes the invention and the manner in which it is to be performed.

FIELD OF INVENTION
The present invention relates to a composition for the treatment of leucoderma and methods for preparation thereof. More particularly it relates to a composition that cures and stops progression of leucoderma which is cheap and can be made easily available.
BACKGROUND OF THE INVENTION
Leucoderma, also referred to as vitiligo, is a skin condition characterized by patchy loss of pigmentation from a person’s skin. The specific causes of vitiligo are unknown; leucoderma is a progressive, idiopathic, hypopigmentation and acquired depigmentary disorder of skin. However, the depigmented areas are lacking in the skin pigment melanin, and the disease is the result of the destruction or inhibition of the melanin secreting melanocytes in the affected areas. There may be some hereditary component to the disease, since approximately 30% of the cases have a familial correlation. It is speculated that the disease may be the result of an autoimmune condition. It is also possible that a specific metabolic defect may be involved, and in some instances, environmental factors appear to play a role.
Allopathic are only suppressive therapy but not curative i.e. it only cures the symptoms not the root cause of the disease. In some instances, leucoderma can be treated with topical corticosteroids, which can stimulate melanin production, possibly by reducing immune reactions. In some instances, melanin production is stimulated by treating the patient with photosensitizing drugs such as psoralen, and then exposing the affected areas of the patient to ultraviolet light. In those instances where the depigmentation is not too extreme, cosmetic preparations may be used as a cover up. Some limited use of skin grafts has also been made.
Certain plant remedies, usually administered as mixtures of herbs or extracts, particularly those used in traditional Chinese medicine and Indian Ayurvedic medicine, have been employed for the treatment of vitiligo for a long time and in many cases have given positive results in small scale studies. Herbs such as Psoralea corylifolia L. and Vernonia anthelmintica Willd. are well known for their use in this disease.
Priyanka Soni, Ravi Patidar, Vishal Soni, Sweta Soni: A Review on Traditional and Alteranative Treatment For Skin Disease “Vitiligo”; International Journal of Pharmaceutical & Biological Archives; 1(3): pp. 220 – 227, 2010 discloses the traditional medicine for treatment of vitiligo such as Psoralea seeds combined with Tamarind seeds, Red clay Radish seeds, Turmeric and Mustard oil. The herb treatment provides the treatment for vitiligo and herbs are reported as antivitiligo agents like Ammi visnaga, milk thistle and Tribulus terrestris.
US2012039928 describes an extract of a processed herbal medicinal plant and a composition for skin external application which contains the extract. More specifically, the composition for skin external application contains an extract as an active ingredient selected from the group consisting of herbal medicinal plant extracts Terminalia chebula, Pueraria, Angelica koreana, Chrysanthemum indicum, Dried Rehmannia, Rhus verniciflua, Licorice, Dried ginger, Pharbitidis, Cassia obtusifolia, Picrasma quassioides, Angelica tenuissima, Sophora flavescens, Caragana chamlagu, Trichosanthes, Agastache rugosa, Selaginella involvens, Lonicera japonica, Chrysanthemum zawadskii, Chrysanthemum indicum, Plazycodon grandiflorum, Cudrania zricuspidala and Arisaema amurense etc. which shows an improved antioxidant effect.
US2011014149 states a combination for skin external use for promoting the differentiation of skin keratinocytes, restoring impaired skin barrier function and increasing skin moisturization compared to extracts obtained by extracting each of the herbs alone.
2901/DEL/2008 discloses a synergistic herbal formulation which comprises extracts of Psoratea corylifoila, Nicotiana tabacum, Polygonum lanigerumt, Onosma hispidum, Commiphora mukul, Saraca indica, Hydnocarpus kurzii and Hedychium spicatum in a form of cream/lotion which can be applied on skin disorders especially in Leucoderma, psoriasis and eczema.
1414/KOL/2013 relates to the herbal composition for treatment of leucoderma as well as cancer, aids, leprosy etc. which is prepared by grinding and mixing of Indian gooseberry, wood apple, five leaved chest tree, garlic etc which are roasted in sunrays and rice, mustard seed, black pepper, cinnamon, dry coconut, black cumin seed, carom seed, black beaten gram etc which are roasted in sunray and oven.
Current treatments which include the use of photosensitisers (e.g. psoralens) with UVA radiation (PUVA), corticosteroids or skin grafting have low success rates and are generally accompanied by unpleasant side effects.
In many instances, treatment is unsuccessful, and some patients opt for chemical bleaching of the remaining pigmented skin so as to produce an even complexion. Therefore, there is still a need for improved treatment methodologies.
Hence, it is desperately needed to invent a natural product which boosts immune system with anti-leucoderma therapeutic properties that contains natural ingredients to reach effective anti-leucoderma action by reducing the free radicals caused by oxidative stress and by other internal and external factors.

OBJECT OF INVENTION

The main object of the present invention is to propose a composition for treatment of leucoderma.

Another object of the present invention is to propose a preparation of a fix dose of ayurvedic composition for treatment of leucoderma.

Yet another object of the present invention is preparation of fix dose for the treatment of leucoderma which is efficient even for advanced stages of the disease.

Further object of the present invention is to provide formulation in quick effective, safe with no side effects which requires no additional radiation and chemical treatment.

Still yet another object of the present invention is to stop the recurrence of the skin disorders following completion of the treatment regimen.

SUMMARY OF THE INVENTION

The present invention is aimed at composition for the treatment of leucoderma. The composition comprises range consisting of: Psoralea corylifolia extract in a range of between 150-1500 gm, Emblica officinalis extract in a range of between 250-1500 gm, Terminallia chebula extract in a range of between 250-800 gm, Terminalia bellirica extract in a range of between 250-300 gm, Piper longum extract in a range of between 10-200 gm, Piper nigrum extract in a range of between 10-200 gm, Plumbago zeylanica extract in a range of between 10-200 gm, Picrorhiza kurroa extract in a range of between 140-400 gm, Swertia chirayata extract in a range of between 50-400 gm, Tinospora cordifolia extract in a range of between 50-1000 gm, Cyperus rotundus extract in a range of between 10-1000 gm, Cuminum cyminum extract in a range of between 10-70 gm , Embelia ribes extract in a range of between 100-300 gm, Asphaltum punjabianum extract in a range of between 50-2000 gm, Semecarpus anacardium extract in a range of between 250-1500 gm, Cinnamonum zeylanicum extract in a range of between 10-150 gm, loha bhasma powder in a range of between 200-1000 gm, Mesua ferrea extract in a range of between 5-70 gm, Crocus sativus extract in a range of between 5-150 gm, Inula recemosa extract in a range of between 50-200 gm, mercury sulphate powder in a range of between 150-800 gm, Sulphur powder in a range of between 250-1500 gm, abhrak bhasma powder in a range of between 200-2400 gm, tamra bhasma powder in a range of between 70-400 gm, Cimmiphora mukul extract in a range of between 100-1800 gm, Acconitum ferox extract in a range of between 50-800 gm, Pongamia pinnata extract in a range of between 300-500 gm, Zingiber officinale extract in a range of between 10-150 gm, alum powder in a range of between 50-300 gm, Pterocarpus santalinus extract in a range of between 250-1500 gm, dry ginger powder in a range of between 10-200 gm, peepramul powder in a range of between 10-200 gm, Glycyrrhiza glabra extract in a range of between 10-200 gm, Shadguna jarit extract in a range of between 50-350 gm, Ocimum tenuiflorum extract in a range of between 10-400 gm, Azadirachta indica extract in a range of between 10-200 gm, Acorus calamus extract in a range of between 20-350 gm, Trachyspermum ammi extract in a range of between 10-150 gm, Centratherum anthelminticum extract in a range of between 10-300 gm, Rubia cordifolia extract in a range of between 10-300 gm, Nardostachys jatamansi extract in a range of between 40-300 gm, Berberis aristata extract in a range of between 20-300 gm, Rosa centifolia extract in a range of between 50-1000 gm and copper iron sulphide powder in a range of between 50-2000 gm. Preferably, the composition is administered orally, more specifically in capsule formulation. In addition, the treatment method herein discloses the single administration of oral dosage in form of capsule is low in toxicity.

BRIEF DESCRIPTION OF DRAWINGS

The present invention is readily understood with reference to the following specifications and attached drawings wherein:
Figure 1(a) and Figure 1(b) shows side view of patient aged fourteen years treated with presently invented capsule made of herb extracts before and after treatment of 90 days respectively.
Figure 2(a) and Figure 2(b) shows front views of hands before and after 90 days on patient aged 36 years treated with presently invented capsule respectively.
Figure 2(c) and Figure 2(d) shows frontage view of legs on patient aged 36 years before and after treatment of 90 days with presently invented capsule respectively.
Figure 3(a) and Figure 3(b) shows front view of legs before and after treatment of presently invented capsule with 180 days on 42 years of aged patient respectively.
Figure 4(a) and Figure 4(b) shows front images of hands before and after 60 days of treatment with presently invented capsule on patient aged 26 years respectively.
Figure 4(c) and Figure 4(d) shows front view images of legs before and after treatment of 90 days with presently invented capsule on patient aged 26 years respectively.
Figure 5(a) and Figure 5(b) shows image of obverse view of legs of 14 years aged patient treated with presently invented capsule before and after 90 days respectively.
Figure 6(a) and Figure 6(b) shows front view of legs treated with presently invented capsule before and after 90 days of conduct on 36 years aged patient respectively.

DETAILED DESCRIPTION
Before explaining the present invention in detail, it is to be understood that the invention is not limited in its application to the details of the construction and arrangement of parts illustrated in the accompany drawings. The invention is capable of other embodiments, as depicted in different figures as described above and of being practiced or carried out in a variety of ways. It is to be understood that the phraseology and terminology employed herein is for the purpose of description and not of limitation.

The present invention is directed to materials and process of preparation thereof for the treatment of leucoderma. Treatment includes ingestion of systemic preparation, most preferably with the oral formulation. The Present invention provides systemic composition based upon combinations of ayurvedic ingredients and a simple process for preparing standardized ayurvedic capsule made up of medicinally rich herb extracts Psoralea corylifolia extract, Emblica officinalis extract, Terminallia chebula extract, Terminalia bellirica extract, Piper longum extract, Piper nigrum extract, Plumbago zeylanica extract, Picrorhiza kurroa extract, Swertia chirayata extract, Tinospora cordifolia extract, Cyperus rotundus extract, Cuminum cyminum extract, Embelia ribes extract, Asphaltum punjabianum extract, Semecarpus anacardium extract, Cinnamonum zeylanicum extract, loha bhasma powder, Mesua ferrea extract, Crocus sativus extract, Inula recemosa extract, mercury sulphate powder, Sulphur powder, abhrak bhasma powder, tamra bhasma powder, Cimmiphora mukul extract, Acconitum ferox extract, Pongamia pinnata extract, Zingiber officinale extract, alum powder, ferrous sulfate powder, Pterocarpus santalinus extract, dry ginger powder, peepramul powder, Glycyrrhiza glabra extract, Shadguna jarit extract, Ocimum tenuiflorum extract, Azadirachta indica extract, Acorus calamus extract, Trachyspermum ammi extract, Centratherum anthelminticum extract, Rubia cordifolia extract, Nardostachys jatamansi extract, Berberis aristata powder for treatment of leucoderma disease. The source of the extract is taken from Bhagwati Herbal and Healthcare Pvt. Ltd, Vapi.
Emblica officinalis is a small fruit also known as Indian Gooseberry which is well acknowledged for its support of antioxidant activity and promotes collagen and elastin production.
Psoralea corylifolian is a renowned herb and is a rich source of naturally occurring psoralen. It sensitizes human skin to the tanning effect of UV and sunlight. Autoimmune destruction is one of the major causes of destruction of melanocytes.
Terminallia chebula is a prominent revitalizing herb. It has a strong laxative effects and useful in treating inflammation of gut and fighting parasites.
Terminallia bellirica is rejuvenating in nature which helps in healthy formation of three bodily tissues known as nutrient plasma, Muscle and Bone.
Piper nigrum (Black pepper) is perennial and metabolic booster. It has antioxidant and antibacterial property which helps in combating aging symptoms and obesity.
Piper longum (long pepper) cures digestion related disorders and also results in curing toothache and heart related disorder. It is bitter, hot and warm in nature and its root contain mainly characteristic of piperin and glucosides.
Zingiber officinale (Ginger) is rich in various medicinal properties, works as antimicrobial agent and has some antifungal as well as anti-inflammatory properties and known to be effective as immuno-modulatory agents in human.
Plumbago zeylanica contains the main chemical compound known as plumbagin which helps to reduce skin inflammation and filariasis. It is also efficient to increase appetite and very effective in bronchitis as well as in reducing swelling.
Picrorhiza kurroa is identified as a cooling agent, aids to remove excessive fire energy from the body. It relief’s acidity and fat which can cause digestion problems. It even restrains various important phytochemicals that play an immense role to cure diseases as well as acts as a metabolic booster.
Swertia chirayata is used as a laxative and also helps in bringing normality in to the system. It mainly follows towards relieving nausea and biliousness and used as vermifuge, tranquilizer and alterative. Swertia is immensely known for its characteristic of reducing rashes and inflamed skin problems.
Tinospora cordifolia is an herb which enhances vitality. The plant extract may also contain phytoandrogen, which can protect against DNA damage induced by the environment and radiation therapy. It has a major adaptogen like properties and works as an immunomodulator.
Cyperus rotundus (Nutgrass) is perennial plant having significance in indigestion, intestinal parasites, mal-absorption and dysentery. It has strong radical scavenging action which Prevents free radical damage of cells and has ability to destroy parasitic worms.
Cuminum cyminum is particularly meant for digestion and acts naturally in effective way balancing diabetes and gives strength and stamina. It is also useful in treatment of piles and leucorrhea.
Embelia ribes is considered to support the intestines and commonly known as false black pepper because of its appearance and its nature. It is a versatile herb used to cure diseases like worm infestation. It mainly describes anti-helminthic effect and tonic to strengthen and to provide energy to body.
Asphaltum punjabianum is the most important drug of Ayurvedic and folk- medicine systems. In the raw form it is a bituminous substance, which is a com pact mass of vegetable organic matter com posed of dark red gummy matrix. It is bitter in taste.
Semecarpus anacardium is found in traditional system of medicines for various ailments. It contains biologically active compounds such as biflavonoids, phenolic compounds, bhilawanols, minerals, vitamins and amino acids, which show various medicinal properties.
Calx of iron balances acidity and fat as well as indicated mainly in treatment of ayurveda for Vitamin C deficiency, general debility and malnutrition due to the content of having iron and copper sulphate calx.
Cinnamomum zeylanicum (cinnamon) contains the anti-oxidant glutathione and a type of flavonoid aiding in digestion and compounds called catechins which help out in relieving nausea.
Mesua ferrea is a splendid herb also known as Indian rose chestnut which is a tonic to heart and digestive system. It is anti peptic, antipyretic and antiallergic herb.
Crocus sativus (saffron) is known for its flavoring agent, food coloring and traditional herbal medicine. A carotenoid compound, crocin, gives the herb its distinct color. It contains minerals like potassium, which control heart rate and blood pressure, and vitamins A and C, folic acid, niacin and riboflavin having significant effects including antidepressant and anticonvulsant. Saffron plays a key role to cure different disorders related to digestive system.
Inula recemosa is an herb that pacifies water and air humors in body. It is widely used in ayurveda due to its main chemicals lantalactone, inunolide and lactone for treatment of asthma, chest pain, edema, facial paralysis and low hemoglobin level.
Mercury sulphate is odorless white granules or crystalline powder has been employed therapeutically as purgatives, antisyphilitics, disinfectants and astringents.
Sulfur makes up vital amino acids to create protein for cells and tissues for hormones, enzymes and antibodies and even controls carbohydrate metabolism. Sulfur detoxifies at the cellular level and relieves pain.
Abies spectabilis (Calcined copper) is the calcination of the mineral, mica. It is an established Rejuvenative tonic, used as nourishment and promotes longevity by preventing aging and by making the body young. Calcined copper contains iron as major element and magnesium, potassium, calcium, and aluminum in traces.
Cimmiphora mukul is made from sap (gum resin) of Commiphora mukul tree. The primary chemical constituents of Guggul include phytosterols, gugulipids, and guggulsterones which mitigate arthritis, skin diseases and pain.
Acconitum ferox is analgesic herb having anti-rheumatic properties. In ayurveda it also helps to cure fever and treat Fruits of this plant are bronco-dilator and anti-inflammatory in nature.
Pongamia pinnata worked predominantly as tooth brush in ancient times, lessen abdominal tumour and bloating. Its leaves are best source to balance fat and acid level.
Alum is a salt of an alkali metal. Alum is an astringent/styptic and antiseptic.
Ferrous sulfate is a mineral-based ayurvedic medicine, which contains ferrous sulfate and is green in color. It is also known as Green vitriol. It is indicated in liver and spleen enlargements, consumption, anemia, skin diseases, eye diseases etc.
Pterocarpus santalinus (Red sandalwood) is perennial and similar to white sandalwood. It has powerful anti-inflammatory, anti-aging and skin lightening properties. It has been widely used as toner for skin. The oil of sandalwood is useful for treating Gonorrhea.
Zinzibe officinale (Dry Ginger powder) has anti-inflammatory properties that can soothe arthritis. It can cure stomach irritation and aids in relieving headache. It can also be taken in order to increase metabolism rate that will burn off stored fat in the body. It is also useful to reduce cholesterol and triglyceride levels in the body.
Peepramul can be used in its powder form as an Indian natural remedy which helps in digestion and even remove gastric problems. It is rich in magnesium and calcium. It is very hot in nature.
Glycyrrhiza glabra is also known as licorice which benefits in providing good strength and immunity. It is excellent remedy for throat disorders, good for improving voice. It is also useful in relieving wasting disorders and degenerative diseases.
Shadguna jarit is used to boost immune system, to improve strength, in cardiac diseases, colicky abdominal pain, urinary tract related diseases, inflammatory conditions, tuberculosis, chronic respiratory conditions, non healing wounds, and digestive problems. It is used as general co prescription to improve immunity.
Abies spectabilis (Calcined copper) is a very good emetic source and produces instant vomiting in all ailments and in poison that has gone inside in particular. It is mainly used in the treatment of predominance diseases and helminthiasis.
Ocimum tenuiflorum is known as holy basil leaves which helps in relieving bad breath issue. It has good smell but and even improves digestion.
Azadirachta indica (Neem) is also called as Margosa tree. It imparts cooling qualities to the body. It helps in absorbing moisture from the intestine. It has pungent taste which undergoes taste conversion after digestion. It is also useful in fever due to its potent anti microbial phyto-chemicals.
Acorus calamus mainly induces uterine contractions; hence it is used in inducing delivery. It relieves joint stiffness and helps in treating obesity. It has been widely used for treatment of depression and blood pressure.
Trachyspermum ammi is also known as Bishop’s weed useful in indigestion, anorexia and haemorrhage. It has been highly used in anemia, fistula and spleen related disorders.
Centratherum anthelminticum is an ancient Indian spice. It is widely used in after delivery care of the mother. It is good for eyes, bloating and vomiting. It is also used for cleaning teeth and improving taste.
Rubia cordifolia is used extensively in the treatment of skin disorders such as eczema and dermatitis. The plant is categorized under the group which enhances the skin complexion.
Nardostachys jatamansi is particularly used in neuro-psychiatric diseases and skin diseases. It is called as spikenard and useful for improving brain functions and intelligence.
Berberis aristata (Indian Barberry) is used to treat eye disorders, skin disorders with itching, diabetes and mainly urinary tract diseases. The root bark contains berberine which has antibacterial, antifungal, antiviral and antioxidant, anti-inflammatory, anti-tumor and anti-diabetic activities.
Rosa centifolia is commonly known as Indian cabbage rose. It is a plant which is abundantly cultivated throughout the world for its cosmetic value and medicinal purpose. It is used for blood purification, diarrhea and anti-inflammatory action.
Copper iron sulphide is prepared from mineral of copper and iron pyrite. It is used in the treatment of various diseases like jaundice, heartburn, bleeding piles, anemia, and headache with pulsating pain or feeling of burning sensation or heat.

A mixture of leucoderma treatment characterized in that, the quality of medicine per dose of the mixture containing the following herb range consists of: Psoralea corylifolia extract 150gm-1500gm, Emblica officinalis extract 250gm-1500gm, Terminallia chebula extract 250gm-800 gm, Terminalia bellirica extract 250gm-300gm, Piper longum extract 10gm-200gm, Piper nigrum extract 10gm-200gm, Plumbago zeylanica extract 10gm-200gm, Picrorhiza kurroa extract 140gm-400gm, Swertia chirayata extract 50gm-400gm, Tinospora cordifolia extract 50gm-1000gm, Cyperus rotundus extract 10gm-100gm, Cuminum cyminum extract 10gm-70gm, Embelia ribes extract 100gm-300gm, Asphaltum punjabianum extract 50gm-2000gm, Semecarpus anacardium extract 250gm-1500gm, Cinnamonum zeylanicum extract 10gm-150gm, loha bhasma powder 200gm-1000gm, Mesua ferrea extract 5gm-70gm, Crocus sativus extract 5gm-150 gm, Inula recemosa extract 50gm-200gm, mercury sulphate powder 150gm-800gm, sulphur powder 250gm-1500gm, abhrak bhasma powder 200gm-2400gm, tamra bhasma powder 70gm-400gm, Cimmiphora mukul extract 100gm-1800gm, Acconitum ferox extract 50gm-800gm, Pongamia pinnata extract 300gm-500gm, Zingiber officinale extract 10gm-150gm, Alum powder 50gm-300gm, Pterocarpus santalinus extract 250gm-1500gm, dry ginger powder 10gm-200gm, peepramul powder 10gm-200gm, Glycyrrhiza glabra extract 10gm-200gm, Shadguna jarit extract 50gm-350gm, Ocimum tenuiflorum extract 10gm-400gm, Azadirachta indica extract 10gm-200gm, Acorus calamus extract 20gm-350gm, Trachyspermum ammi extract 10gm-150gm, Centratherum anthelminticum extract 10gm-300gm, Rubia cordifolia extract 10gm-300gm, Nardostachys jatamansi extract 40gm-300gm, Berberis aristata extract 20gm-300gm, Rosa centifolia extract 50gm-1000gm and copper iron sulphide powder 50gm-2000gm

The foregoing materials are pulverized and filled into capsules. A typical daily dosage of the material is 3 grams, preferably taken one gram in three times portions. While the foregoing composition represents one preferred embodiment, it will be appreciated by those of skill in the art that proportions of the various ingredients may be increased or decreased in accord with the table 1 of present invention.

The invention is illustrated more in detail in the following example. The example describes and demonstrates embodiments within the scope of the present invention. This example is given solely for the purpose of illustration and is not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope.
Example: 1
Table-I

Sr. no. Components Amount of extract (Grams)
1 Psoralea corylifolia 800gm
2 Emblica officinalis 1000gm
3 Terminallia chebula 500gm
4 Terminalia bellirica 500gm
5 Piper longum 50gm
6 Piper nigrum 50gm
7 Plumbago zeylanica 150gm
8 Picrorhiza kurroa 250gm
9 Swertia chirayata 250gm
10 Tinospora cordifolia 1000gm
11 Cyperus rotundus 10gm
12 Cuminum cyminum 100gm
13 Embelia ribes 80gm
14 Asphaltum punjabianum 700gm
15 Semecarpus anacardium 1000gm
16 Cinnamonum zeylanicum 50gm
17 Loha bhasma (calx of iron) 200gm
18 Mesua ferrea 20gm
19 Crocus sativus 50gm
20 Inula recemosa 100gm
21 Mercury sulphate 400gm
22 Sulfur 700gm
23 Abhrak bhasma 1800gm
24 Tamra bhasma 180gm
25 Cimmiphora mukul 400gm
26 Acconitum ferox 200gm
27 Pongamia pinnata 736gm
28 Zingiber officinale powder 50gm
29 Alum powder 150gm
30 Ferrous sulfate (kasis bhasma) 1400gm
31 Pterocarpus santalinus 1000gm
32 Dry ginger powder 50gm
33 Peepramul 50gm
34 Glycyrrhiza glabra 100gm
35 Shadguna jarit 200gm
36 Ocimum tenuiflorum 100gm
37 Azadirachta indica 80gm
38 Acorus calamus 100gm
39 Trachyspermum ammi 50gm
40 Centratherum anthelminticum powder 1000gm
41 Rubia cordifolia 100gm
42 Nardostachys jatamansi 200gm
43 Berberis aristata 150gm
44 Rosa centifolia 300gm
45 Copper iron sulphide 700gm

CAPSULE MAKING
One accomplishment of the present invention may be illustrated by formulation of all the above herb extracts in capsule form with said proportions. All active ingredients for 1 capsule = 500mg were mixed thoroughly. The powder was filed in number "0" capsule. The preparation according to the invention has been administered to a number of patients and the results have been quite heartening.
TOXICITY STUDY OF CAPSULE

The oral composition in form of capsule can be single administered for relatively long period of time i.e. acute oral toxicity study (as per OECD 425 guideline) is noted subsequently for fifteen days.

An experiment was carried out for analyzing the effect of capsule having extract in sufficient quantity ranging from 2000-3000mg/kg on the Female Wistar rats (obtained from Cadila pharmaceuticals ltd. Ahmedabad). Rats were chosen, particularly these species are in general used for nonclinical and toxicity evaluations.

Laboratory bred and experimentally naïve six adult female rats were taken with approximately 12-13 weeks of age and 450-490 grams weight at time of randomization. The environmental conditions of the animal room were maintained as per Guideline of Committee for the purpose of control and supervision of experiments on animals (CPCSEA). The animal feed was provided (from Pranav Agro Science, Pune) and deionised water provided with ad libitum. No contaminants were known to be present in the certified diet that interfered with the results of the study.
Table-II
Group assignment and dose
Dose Group Animals Test Article Dose level
(mg/kg)
1 M (n=6) Capsule 2000 mg/kg

Table-III
Acute oral toxicity of capsule for evaluation parameter:
Open field Activity
O hour 1 hour 2 hour 3 hour 4 hour
Animal Mark No of crossing Rearing No of crossing Rearing No of crossing Rearing No of crossing Rearing No of crossing Rearing
H 25 8 19 6 10 3 13 3 16 2
B 14 3 10 1 3 1 10 3 14 2
T 31 2 7 5 4 1 8 2 8 2
HT 26 6 21 2 9 1 14 3 19 2
BT 32 4 32 2 23 1 16 2 28 2
U 15 4 15 4 8 2 10 2 12 1
Average 23.83333 4.5 17.3333 3.3333 9.5 1.5 11.8333 2.5 16.1667 1.83333
SD 7.73089 2.16795 8.91441 1.9664 7.17635 0.83666 2.99444 0.5477 6.88234 0.40825
SEM 3.156123 0.88506 3.63929 0.8028 2.92973 0.34157 1.22247 0.2236 2.80971 0.16667

Table-IV
Acute oral toxicity of capsule for evaluation parameter:
Locomotor Activity (Photoactometer)
O hour 1 hour 2 hour 3 hour 4 hour
Animal Mark Count Count Count Count Count
H 206 106 125 139 168
B 213 109 140 146 173
T 229 116 156 169 189
HT 200 100 200 196 178
BT 318 64 203 186 210
U 289 77 8 89 103
Average 242.5 95.33333 138.6667 154.1667 170.1667
SD 49.09888 20.33388 71.36292 38.79905 36.12986
SEM 20.04453 8.301272 29.13379 15.83965 14.74995

Table-V
Acute oral toxicity of capsule for evaluation parameter:
Detailed Clinical Observation (Dose: 2000mg/kg)
Change at specific time interval (hour)
Animal Mark Observation Parameter 0 0-30 1 2 3 4 4-12 12-24 After 24
H, T,
BT, B,
HT, U Fur White White White White White White White White White
Tremor NO NO NO NO NO NO NO NO NO
Salivation NO NO NO NO NO NO NO NO NO
Diarrhoea NO NO NO NO NO NO Yes NO NO
Lethargy NO NO NO NO NO NO Yes NO NO
Sleep NO NO NO NO NO NO NO NO NO
Respiratory Normal Normal Normal Normal Normal Normal Normal Normal Normal
Behavior Normal Normal Normal Normal Normal Normal Normal Normal Normal
Mortality NO NO NO NO NO NO NO NO NO

Table-VI
Acute oral toxicity of capsule for evaluation parameter:
Body weight (gm)
Mark 0 7 14
H 492 490 499
B 486 463 468
T 457 503 503
BT 453 443 462
HT 460 455 473
U 432 434 436
AVG 471.5 483 485.5
SD 20.50609665 28.28427125 24.74873734
SEM 11.83920042 16.32993162 14.28869017

Table-VII
Acute oral toxicity of capsule for evaluation parameter:
Feed intake (gm)
1 2 3 4 5 6 7 8 9 10 11 12 13 14
60 80 62 72 60 60 73 54 72 86 92 101 100 108

Table-VIII
Acute oral toxicity of capsule for evaluation parameter:
Organ Weights
Animal Mark Liver Kidney Brain Heart Lungs
HT 14.89 2.77 2.01 1.62 2.52
BT 13.76 2.43 2.12 1.41 2.31
U 14.62 3.04 2.11 1.39 2.45

OBSERVATION

The treatment agents of the present invention have been found to be highly effective in bringing out repigmentation of areas of the skin manifesting leucoderma. The systemic composition in the form of capsule are low in toxicity and can be administered for relatively long periods of time; although marked improvement of the condition is noted following fourteen days of treatment.

Evaluation Paramater Observation
Effect of Test article on animal body weight No significant changes in body weight after administration of test article in animals
Effect of Test article on animal feed consumption No significant changes in feed consumption after administration of test article in animals
Effect of Test article on Autonomic nervous system (ANS) and Central nervous system (CNS) activity As shown in Table III and IV Open field test and Actophotometer test was carried out which marks decrease in locomotor activity up to four hours after dose administration

CONCLUSION:

No sign of skin/eye irritation, tremors, convulsion, salivation, Diarrhoea, lethargy, sleep and coma were observed, Table VI and Table VII indicates body weight and feed intake normal after 14 days of observation, Table VIII signifies histology of organs like brain, lungs, heart, liver and kidney and no mortality and toxicity were observed in animal after 14 days of gross necropsy.
Further a single oral dose of 2000mg/kg of extract administration in animal followed up by daily two times and up to four hour observation. Locomotor activity was decreased whereas body weight and feed consumption were normal. No significant difference seen in histology of major organs. (As per OECD guidelines 423, The LD50 of capsule was found as to be orally taken as 2000-5000 mg/kg.)
The treatment is based on administering the preparation in daily doses with very low concentration of the constituents of total weight of contents of three grams. The groundwork has been used for treating leucoderma and has been predominantly useful when the disease is detected in the early stages or the later stages.
While the present invention has been described with respect to what is presently considered to be the preferred embodiments, it is to be understood that the invention is not limited to the disclosed embodiments. To the contrary, the invention is intended to cover various modifications and equivalent ranges included within the spirit and scope of those skilled in the art. It is expressly understood, however, that such modifications and range are within the spirit and scope of the present invention as set forth in the following claims.

I Claim:-
1. A composition for treatment of leucoderma comprises Psoralea corylifolia extract 150-1500 gm, Emblica officinalis extract 250-1500 gm, Terminallia chebula extract 250-800 gm, Terminalia bellirica extract 250-300 gm, Piper longum extract 10-200 gm, Piper nigrum extract 10-200 gm, Plumbago zeylanica extract 10-200 gm, Picrorhiza kurroa extract 140-400 gm, Swertia chirayata extract 50-400 gm, Tinospora cordifolia extract 50-1000 gm, Cyperus rotundus extract 10-1000 gm, Cuminum cyminum extract 10-70 gm, Embelia ribes extract 100-300 gm, Asphaltum punjabianum extract 50-2000 gm, Semecarpus anacardium extract 250-1500 gm, Cinnamonum zeylanicum extract 10-150 gm, loha bhasma powder 200-1000 gm, Mesua ferrea extract 5-70 gm, Crocus sativus extract 5-150 gm, Inula recemosa extract 50-200 gm, mercury sulphate powder 150-800 gm, sulphur powder 250-1500 gm, abhrak bhasma powder 200-1800 gm, tamra bhasma powder 70-300 gm, Cimmiphora mukul extract 100-1800 gm, Acconitum ferox extract 50-800 gm, Pongamia pinnata extract 300-500 gm, Zingiber officinale extract 10-150 gm, alum powder 50-300 gm, Pterocarpus santalinus extract 250-1500 gm, dry ginger powder 10-200 gm, Peepramul powder 10-200 gm, Glycyrrhiza glabra extract 10-200 gm, Shadguna jarit extract 50-350 gm, Ocimum tenuiflorum extract 10-400 gm, Azadirachta indica extract 10-200 gm, Acorus calamus extract 20-350 gm, Trachyspermum ammi extract 10-150 gm, Centratherum anthelminticum extract 10-300 gm, Rubia cordifolia extract 10-300 gm, Nardostachys jatamansi extract 40-300 gm, Berberis aristata extract 20-300 gm, Rosa centifolia extract 50-1000 gm and copper iron sulphide powder 50-2000 gm.
2. The composition for treatment of leucoderma as claimed in claim 1, wherein administering said composition orally in the form of capsule to the patient.
Dated this 5th day of December 2017.
ABSTRACT

A composition for treatment of Leucoderma

The present invention relates to a composition for treatment of leucoderma. It particularly relates to a mixture of herb extracts for the treatment of leucoderma. The formulation comprises different herb extracts reported as anti-leucodermal agents in a capsule form. The formulation provides natural remedies for leucoderma which reduces white patches on skin without any toxicity and side-effects. It reduces infection and irritation of the skin as well as boosts immune system. Leucoderma is produced by melanin which is a skin pigment and secreted by melanocytes (cells present in the skin), this formulation helps in inducing the production of the melanin and hence results in giving normal color to the skin.