Technical field of the invention:
The present invention relates to novel synergistic herbal compositions used for the treatment of psoriasis, psoriatic arthritis and dermatitis comprising of extracts of Wrightia tinctoria, Ocimum sanctum, Azadirachta indica, Santalum rubrum and Acacia catechu. The present invention further relates to a process for the preparation of the said novel herbal compositions.
Background and prior art:
Psoriasis is an inflammatory skin condition. There are five types, each with unique signs and symptoms. In some conditions the patients develop a related form of arthritis called "psoriatic arthritis," which causes inflammation of the joints.
Psoriasis is characterized by inflammatory and abnormal epidermal keratinocyte hyper-proliferation resulting in hyperplasia, thickening of the epidermis and presence of red scale plaques. The chronic skin condition recognized for its peculiar clinical symptoms, characterized by circumscribed red patches covered with white scales result in itchy flaky skin. Psoriasis is a very visible disease and frequently affects the face, scalp, trunk and limbs. The lesions in this chronic disease typically are subjected to remissions and excerbations.
Research stipulates that psoriasis is an immune-mediated condition, where activated T-lymphocytes, producing multiple cytokines cause secondary epithelial abnormalities. Dysregulated lymphocytes produce cytokines that stimulate the proliferation of apoptosis-resistant keratinocytes. Psoriatic skin lesions are characterized by inflammation, with T cells and neutrophils infiltrating both the dermis and epidermis and excessive scaling related to epidermal hyperproliferation and aberrant keratinocyte differentiation (Reich, et. al., 2001). The defect in psoriasis appears to be overly rapid growth of keratinocytes and shedding of scales from the skin surface.

The symptoms observed in psoriatic patients include hyperplasia and abnormal cornification of epidermal cells ascribed to the excess turnover of the cells by hyper metabolism, asthenia of inflammatory response in the epidermal layer, vasodilatation and leukocyte migration and infiltration into the epidermal cell layers (Beutner, 1982). Epidermal hyperplasia is a reaction to the activation of immune system in focal skin regions, which in turn, is mediated by CD8+ and CD4+ T lymphocytes that accumulate in the diseased skin. Psoriasis is recognized as the most prevalent T cell-mediated inflammatory disease of humans.
Specific systemic therapies include UVB, PUVA, methotrexate, vitamin A derivatives (acitretin) and immuno-suppressants such as Cyclosporin A. The effectiveness of Cyclosporin and FK-506 for treating psoriasis provides support for the T cell hypothesis as the prime cause of the disease.
The topical use of corticosteroids reduces the symptoms of psoriasis. However their administration for long period of time, which is necessary in such treatment causes tachyphylaxis so that either the dose has to be increased or stronger drugs has to be used leading to atrophy and achromasia or loss of pigmentation of peripheral normal skin, when it is topically applied on psoriatic lesion.
Also are available some topical therapies like coal tar preparation. Although this is the most frequently used topical therapy, coal tar has a bad odor and stains clothing. Coal tar is effective for psoriasis because it is toxic to T cells.
Other topical formulation include anthralin cream or high dose/short duration anthralin in salicylic acid in petroleum may be effective, or the topical synthetic retinoid tazarotene, also provides short-term relief, although these are often irritating.
Chemotherapeutic agent like methotrexate, is beneficial in patients with psoriasis. But these agents have disadvantages which include leukopenia and cumulative hepatic toxicity that requires frequent monitoring by fine needle biopsies of the liver. Cyclosporine has recently

been approved for treatment of severe psoriasis, although long term therapy with this drug
may result in hypertension and potential nephrotoxicity.
There are also herbal preparations for the treatment of psoriasis with reduced side effects.
US5858372 discloses a hydrophilic ointment which includes a latex extract derived from the leaves of the Wrightia tinctoria R. Br. plant, urea and polyethylene glycol.
CN1267541 discloses Chinese medicine bolus prepared with sparganium stoloniferum, setose asparagus herb, Cortex Dictamni Radicis, tree peony bark, Rehmannia glutinosa and other seven Chinese medicinal materials in rational proportion with high curative effect and no toxic side effect and used in treating various types of psoriasis.
US2003194456 discloses novel herbal composition containing the extracts of the leaves and/or stem of Argemone mexicana plant, optionally containing the extracts of the fruits of Cuminum cyminum, for the treatment of psoriasis and related immunological and biological disorders.
In view of the aforementioned drawbacks associated with prior art, it is apparent that there exists a need for improved compositions for oral administration and local application which are effective and devoid of side effects. The present invention discloses compositions from natural origin comprising of Wrightia tinctoria, Ocimum sanctum, Azadirachta indica, Santalum rubrum, Acacia catechu useful in controlling dermatitis and psoriasis in particular and also in the prevention of psoriatic arthritis.
Objects of the Invention:
The main object of the present invention is to provide novel synergistic herbal compositions comprising of extracts of Wrightia tinctoria, Ocimum sanctum, Azadirachta indica, Santalum rubrum and Acacia catechu useful for the control of dermatitis and psoriasis in particular and prevention of psoriatic arthritis.

It is a further object of the present invention to provide novel herbal compositions which are safe and possess no side effects.
It is yet another object of the invention to provide a novel process of manufacturing the said herbal compositions.
Summary of invention:
The present invention discloses synergistic herbal compositions comprising of extracts of Wrightia tinctoria, Ocimum sanctum, Azadirachta indica, Santalum rubrum, Acacia catechu as active constituents along with pharmaceutically acceptable excipients in pharmaceutically acceptable dosage form. The compositions of the present invention are useful for the control dermatitis in general and psoriasis in particular and prevents psoriatic arthritis.
Detailed description of the invention:
The present invention describes compositions comprising of Wrightia tinctoria, Ocimum sanctum, Azadirachta indica, Santalum rubrum, Acacia catechu as active constituents along with pharmaceutically acceptable excipients in pharmaceutically acceptable dosage form. The compositions of the present invention are useful in controlling dermatitis in general and psoriasis in particular and prevent psoriatic arthritis. Anatomically the compositions have the potential to maintain the structural health of epithelium and endothelium. Physiologically it has the potential to maintain the blood supply to the skin. The compositions negate the dryness, scaling and morphological changes that occur in dermatic conditions. In accordance with the present invention, it has been found that Wrightia tinctoria, particularly when combined with Ocimum sanctum, Azadirachta indica, Santalum rubrum, Acacia catechu provides synergistic results in treatment of psoriasis and dermatitis.
Wrightia tinctoria belongs to Apocynaceae family. It is found throughout India; Burma and Timor. It is a small, deciduous tree with smooth bark and milky latex. The leaves bark and

the seeds are used for the extraction of the active ingredient. Wrightia tinctoria leaves are acrid, thermogenic, anodyne and hypotensive, and are useful in odontalgia, vitiated conditions of vata and hypertension. The bark and seeds are bitter, astringent, acrid, thermogenic, carminative, digestive, and stomachic, constipating, depurative, anthel- mintic, aphrodisiac and febrifuge. They are useful in vitiated conditions of pitta and kapha, dyspepsia, flatulence, colic, diarrhoea, leprosy, psoriasis, haemorrhoids, dipsia, helminthiasis, fever, burning sensation and dropsy. The latex of the bark and unripe fruits are used by hill tribes for coagulating and solidifying milk.
Ocimum sanctum commonly known as Tulsi is a widely grown, sacred plant of India. It belongs to the Labiateae family. It is also called by names like Manjari/Krishna tulsi in Sanskrit. It is called Holy Basil in English. The natural habitat of Tulsi varies from sea level to an altitude of 2000 m. Tulsi is a branched, fragrant and erect herb having hair all over. It attains a height of about 75 to 90 cm when mature. Its leaves are nearly round and up to 5 cm long with the margin being entire or toothed. These are aromatic because of the presence of a kind of scented oil in them. A variety with green leaves is called Shri Tulsi and one with reddish leaves is called Krishna Tulsi. The flowers are small having purple to reddish color, present in small compact clusters on cylindrical spikes. The fruits are small and the seeds yellow to reddish in color. Tulsi leaves contain a bright yellow volatile oil which has is medicinal virtues and is useful against insects and bacteria. The principal constituents of this oil are Eugenol, eugenol methyl ether and carvacrol. The oil is reported to possess antibacterial properties and acts as an insecticide. It inhibits the in vitro growth of Mycobacterium tuberculosis and Micrococcus pyogenes var. aureus. It has marked insecticidal activity against mosquitoes. The parts of the herb used for extraction of the active are leaves, bark and seeds. The juice of leaves, and or a concoction, called jushanda, a kind of tea, gives relief in common cold, fever, bronchitis, cough, digestive complaints, etc. When applied locally, it helps in eradicating ringworms and other skin diseases. The seeds are used in curing urinary problems. Antimicrobial activity of the essential oil has been shown against M. tuberculosis and Staph aureus in vitro and other bacteria and fungi. Eugenol and methyleugenol showed a positive activity. Oil extracted from Tulsi is used as drops in ear infections. Fungal and bacterial infections of skin are treated with Tulsi juice. The seeds are

used as a general tonic.
Volatile oil 0.4-0.8% containing chiefly eugenol app. 21% & B-caryophyllene 37% (eugenol content reaches maximum in spring & minimum in autumm). A no. of sesquiterpenes & monoterpenes viz., bornyl acetate, β -elemene, methyleugenol, neral, β-pinene, camphene, a-pinene etc.: ursolic acid, campesterol, cholesterol, stigmasterol, β-sitosterol and methyl esters of common fatty acids.

Azadirachta indica is known as Nimba and Arishta in Sanskrit belongs to Meliaceae family. It is a native of India, and is cultivated in all parts of the country on account of its medicinal properties. This tree is found in the Western Himalayas of India, and in Iran. It is cultivated in other parts of India and the tropical regions of the world such as Indonesia, Australia, and West Africa. Neem is a fast growing tree that can reach a height of 15-20 m, rarely to 35-40 m. It is evergreen but under severe drought it may shed most or nearly all of its leaves. The branches are wide spread. The trunk is relatively short, straight and may reach a diameter of 1.2 m. The bark is hard, fissured or scaly, and whitish-grey to reddish-brown. The alternate, pinnate leaves are 20-40 cm long, with 20-31 medium to dark green leaflets about 3-8 cm long. The leaves, bark and other products of neem have been articles of the Hindu materia medica from a very remote period, and are mentioned in the Ayurveda of Susruta. The bark

is considered to be bitter, tonic, and astringent. The leaves are added to poultices to disperse glandular tumours, and are used generally as a discutient; beaten into a pulp they are applied to pustular eruptions, more especially to the eruption of small-pox; their juice is anthelmintic, The leaves beaten to a pulp, and externally applied, act like a charm in removing the most intractable forms of psora and other pustular eruptions." The bark as a febrifuge; others have spoken favourably of the leaves as a local application to ulcers and certain obstinate skin diseases.
Santalum rubrum belongs to Santalaceae, commonly known as Sandalwood is a small tree that grows primarily in India. The wood of its stem, which grows from 20 to 30 feet high, is heavy and straight-grained and varies in color from white when young to yellow or orange when older. Its oval leaves are covered with a whitish bloom; its small flowers, varying in color, grow in numerous cymes. The heartwood is used as the source of sandalwood oil. The heartwood is characteristically aromatic, persistent and tastes peculiar due to the extractives produced when sapwood is converted to heartwood. The essential oil contains high amounts of alpha- and beta-santalol. These small molecules possess antibacterial and sedative properties Sandalwood oil was used traditionally to treat skin diseases, acne, dysentery, gonorrhea, and a number of other conditions. Sandalwood oil is used to treat skin diseases, acne, dysentery, gonorrhea, and a number of other conditions. The oil can also be used for bronchitis and for inflammation in mucous tissue. A decoction of the wood may be helpful for indigestion and fever and externally for skin problems, especially those of bacterial origin. Sandalwood cools and calms the entire body and mind. It affects the circulatory, digestive, respiratory and nervous systems. It relieves fever, thirst, burning sensation and stops sweating. It is good for fever or overexposure to the sun. Sandalwood is good for most of inflammatory conditions and for cleansing the blood. The oil or paste is useful for most infectious sores or ulcers if applied externally
Acacia catechu commonly known as Khair, is a moderate size deciduous tree with rough dark gray brown bark. It belongs to family Leguminoseae-mimoseae. Khair grows naturally all over Haryana and the rest of Indian subcontinent areas experiencing average rainfall, in the whole of the Indo Gangetic plain from Assam westwards, right up to Afghanistan. Also from sea coast to Deccan Plateau and then northwards to the lower Himalayan ranges having

an altitude up to about 1250 m or so. The heart wood is small and red in color. The wood darkens on exposure. Its wood contains catechin, catechutanic acid and tannin. The bark is especially useful as astringent, and a cure in cough, diarrhea and indigestion, cancer, piles, sore throat, ulceration, eczema and certain forms of leprosy. The parts of the herb used for extraction of the active constituent are leaves, bark and seeds. According to ayurveda the said herbs possesses the following properties:

The term "Rasa" indicates primary taste; "Guna" indicates functional properties; "Vipaka" indicates taste at the absorptive level; "Veerya" indicates effect on body as "Ushna" stands for catabolism and "Seetha" stands for anabolism; "Prabhava" indicates effective sphere on body; "Karma" indicates fields of specific actions; and "Nature" indicates the synergistic profile.

The herbal composition may suitably be provided in the form of capsules, tablets, topical cream or ointment and the like.
In one embodiment, the present invention provides soft gelatin capsules. The capsule formulations essentially comprise of the active herbal constituents and coconut oil.
Process for manufacturing of the soft gelatin capsule:
The raw materials particularly, 80gm of Azadirachta indica (bark), 80gm of Santalum rubrum (hard wood) and 80gm of Acacia catechu (hard wood) are taken in equal proportion and cleaned. They are taken in the ratio 240 gm per four litre of water, and heated to reduce the quantity to one forth to obtain a decoction of one litre. The decoction is filtered and to this filtrate well grounded 62.5 gm of whole plant of Ocimum sanctum is added. The decoction mixed well. To 250 ml of coconut oil, the said decoction is added and mixed well to get medicated oil. To one litre of the above medicated oil 300gm of Wrightia tinctoria (in the form of fresh leaves) is added. The medicated oil and Wrightia tintoria mixture is exposed to sunlight for 7 days. The oil is filtered to get the final product and subjected to soft gelatin capsulation to get final soft gelatin capsules.
In another embodiment, the present invention provides an ointment which essentially comprises of the said herbs, coconut oil, white petroleum jelly and honey bee wax.
Process for manufacturing of the ointment:
The raw materials particularly, 80gm of Azadirachta indica (bark), 80gm of Santalum rubrum (hard wood) and 80 gm of hard wood of Acacia catechu are taken in equal proportion and cleaned. They are taken in the ratio 240 gm per four litre of water, and heated to reduce the quantity to one forth to obtain a decoction of one litre. The decoction filtered and to this filtrate well grounded 62.5 gm of Ocimum sanctum (whole plant) is added. The decoction mixed well. To 250 ml of coconut oil, the said decoction is added and mixed well to get medicated oil. To one litre of the above medicated oil 300gm. of Wrightia tinctoria (in the form of fresh leaves) is added. The medicated oil and Wrightia tintoria mixture is exposed to

sunlight for 7 days. The oil is further filtered. To 400gm white petroleum jelly, 100 gm honey bee wax is added and the mixture is further melted. This is further mixed well and filtered. To this the medicated oil is added and stirred well. The oil is filtered to get the final product. This final ointment is packed into tubes.
The present invention is illustrated by the way of the following non-limiting examples. The examples are not limited to the particular embodiments illustrated herein but include the permutations, which are obvious set forth in the description.


The medicated oil is formulated in a pharmaceutically acceptable ointment base.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative examples and that the present invention may be embodied in other specific forms without departing from the essential attributes thereof, and it is therefore desired that the present embodiments and examples be considered in all respects as illustrative and not restrictive, reference being made to the appended claims, rather than to the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Dated this 27th day of July 2006