FORM 2
THE PATENTS ACT - 1970
(39 of 1970)
COMPLETE SPECIFICATION
(See Section 10)
HERBAL MEDICATION FOR TREATMENT OF PSORIASIS
LUPIN LIMITED, 159, CST Road, Kalina, Santacruz(East), Mumbai. Maharashtra
400 098. India
The following specification particularly describes the nature of the invention and the manner in which it is to be performed.


HERBAL MEDICATION FOR THE TREATMENT OF PSORIASIS FIELD OF THE INVENTION
The invention relates to an herbal composition for use in the treatment of psoriasis. In particular, the present invention relates to an oral composition for treatment of psoriasis. Particularly, the present invention relates to an oral composition for treatment of psoriasis based essentially on extracts from the leaves of Argemone mexicana plant. The invention also relates to a method of treatment for psoriasis. BACKGROUND OF THE INVENTION
Psoriasis is a proliferative chronic skin condition recognized for its peculiar clinical symptoms characterized by circumscribed red patches covered with white scales and resulting itchy, flaky skin. The cause and mechanism of the disorder is not very clear (Kruger, 1981) and the current treatments include topical fluorinated corticosteroids, vitamin A, vitamin D, methotrexate, external use of coal tar, ultraviolet irradiation etc. as suppressive therapy. In the case of psoriasis, strong hyperproliferation of epidermal keratinocytes and incomplete epidermal differentiation leads to severe scaling of the affected skin areas in sufferers. This proliferative event is accompanied by inflammation of the epidermis and dermis, with infiltration of T-cells and neutrophils as well as macrophages. Psoriasis is currently viewed as an autoimmune disease, but pathogenesis of the disease is still not known.
The symptoms and phenomenon observed in psoriatic patients include hyperplasia and abnormal cornification of epidermal cells ascribed to the excess turnover of the cells by hypermetabolism, asthenia of inflammatory response in the epidermal layer, vasodilation and polynuclear leukocyte migration and infiltration into epidermal cell layers (Beutner, 1982).
Following therapeutic methods have conventionally been utilized to treat psoriasis:
Corticosteroids: The topical use of corticosteroids reduces the symptoms of psoriasis, however its 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 drug 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. Further, when the internal use of these steroids is interrupted to avoid adverse side effects, withdrawal dermatitis can be caused (BNR2001).
Phototherapy: Use of phototherapy (irradiation with ultravio let radiation) or photochemotherapy, which consists of external or internal administration of psoralens and application of long-wave ultraviolet rays to the affected part, is associated with disadvantages
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of possibility of accelerated aging or pigmentation of the skin and of inducing carcinogenesis (BNF, 2001). External use of coal tar though has fewer side effects when compared with steroids, it is messy and drawbacks include strong odor, staining of skin etc. Occasionally it may cause stimulant dermatitis.
Methotrexate: Patients taking methotrexate for treating psoriatic conditions need to be closely monitored because it can cause liver damage and/or decrease the production of oxygen-carrying red blood cells, infection-fighting white blood cells and clot-enhancing platelets. The long-term use of psoralens and methotrexate significantly increases the risk of squamous cell carcinoma in patients with psoriasis (Stern, 1994).
Retinoids: Retinoids such as etretinate are taken internally for patients suffering from intractable psoriasis, however it is teratogenic and likely to accumulate in the body for a long period of time and hence for a person capable of childbearing it should be avoided (BNF, 2001). Use of cyclosporine may impair kidney function or cause hypertension. Possible side effects of hydroxyurea include anemia and a decrease in white blood cells and platelets.
Calcipotriol: In recent years, calcipotriol, a synthetic vitamin D3 analogue has become one of the widely prescribed treatment for psoriasis. However, it causes significantly more skin irritation than potent topical corticosteroids. The common adverse effects include lesional or perilesional irritation, facial or scalp irritation, or exacerbation of psoriasis (Ashcroft et al, 2000).
The disease is still poorly understood and though many treatments are available none is universally effective and safe. The magnitude of the impact of psoriasis is similar to that of other diseases like depression, hypertension and congestive heart failure. The cost of treating the disease averages 800 US dollars per patient per year in the United States, and the disease can contribute significantly to loss in productivity (Feldman, 2000). Despite the availability of various treatments, psoriasis owing to its sporadic course, variable response to treatments, and adverse effects is a difficult disease to cure.
Apart from the clinical. manifestations and the inconvenience the psychological impact of the disease on the patient's life is tremendous. Psoriasis is a complex condition affecting all aspects of health-related quality of life (Fortune et aL, 1998). Between 1 and 2 % of the world's population suffer from psoriasis. Skin disease like, psoriasis substantially reduces the quality of life for millions of people all over the world. Moreover, as it is often clearly visible, affected individuals suffer marked distress, embarrassment and discomfort.
Thus a great if not imperative need exists for a new, effective treatment for psoriasis, preferably a complete cure i.e. without any relapse and having no serious adverse reactions.
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There have also been some unsubstantiated claims on use of herbal preparations on treatments of various skin disorders such as psoriasis, eczema, and all kinds of rashes, cuts and abrasion and even sunburns. Such claims include complete killing of all "infections" including that of psoriasis. Since the causative factors of all the above mentioned skin conditions and diseases are entirely different and since psoriasis is more likely an auto immune disorder rather than due to any infection, it is extremely unlikely that any herbal preparation is effective as a universal panacea against every single skin problem. Since psoriasis is a skin ailment, use of any herbal preparation poses great dangers of severe allergic reactions, aggravation of the condition or even induction of fungal infections. To the applicants' knowledge there is no prior art, which credibly teaches any herbal preparation which is really effective in the treatment of psoriasis. OBJECTS OF THE INVENTION
It is therefore, an object of the present invention is to provide a composition for use in the treatment of psoriasis with minimal and reversible adverse reactions or side effects.
It is another object of the present invention to provide a method for treatment of psoriasis with minimal and reversible adverse reactions or side effects.
Another object of the present invention is to provide a method for treatment of psoriasis, which minimizes relapse or recurrence of the disease following completion of a treatment regimen.
Yet another object of the present invention is to provide a plant-based composition for use in the treatment of psoriasis with minimal and reversible adverse reactions or side effects. SUMMARY OF THE INVENTION
The above and other objects of the invention are achieved by the novel herbal treatment composition of the invention, which essentially comprises ingredients of extract from leaves of the Argemone mexicana plant. The extract derived from the leaf is believed to contain active ingredient(s) responsible for the beneficial effects of the present invention.
In another preferred embodiment, the composition also includes extracts from the seeds of Cuminum cyminum seeds which interact synergistically with extract from the leaves of the Argemone mexicana plant to not only provide excellent cure of psoriasis but also to reduce any feeling of nausea or headache after administration of the composition.
The composition of the present invention may be provided in a formulation containing extract from the leaves of Argemone mexicana at a concentration between about 2 and about 100 mg/g or ml. It can be preferably administered to a patient consecutively for three days in
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a week for a maximum period of about 12 to about 15 weeks. A typical treatment regimen may include 36 to 45 oral dosages of the composition over a 12 to 15 week period. DETAILED DESCRIPTION WITH REFERNCE TO THE DRAWINGS
The present invention will now be described in greater detail with reference to the accompanying drawing wherein..
Figure 1 is a graph depicting the mean Psoriasis Area and Severity Index (PASI) score of the patients recorded during clinical trials every two weeks during the treatment regimen. The vertical axis lists the mean PASI score for 22 patients with psoriasis and the horizontal axis gives the treatment duration in weeks.
Figure 2 represents a graph depicting reduction in PASI score at the end of every two weeks during treatment regimen in comparison to basal PASI score. The vertical axis lists the reduction in the mean PASI score for 22 patients with psoriasis and the horizontal axis gives the treatment duration in weeks.
Figure 3 represents the assessment of tolerability for a composition of the present invention during clinical testing, depicted as bar graph. The vertical axis lists number of patients (%) and the horizontal axis gives treatment duration in weeks.
The present invention relates to an herbal oral composition comprising an extract from the leaves of the Argemone mexicana plant and a method of treatment of psoriasis employing such extracts. The composition is useful for the treatment of psoriasis. The pharmaceutical composition is, in its simplest form, a mixture of Argemone mexicana leaves, water and optionally Cuminum cyminum.
The extract of the present invention is derived from the leaves of the Argemone mexicana plant. The Argemone mexicana popularly known as Mexican poppy or prickly poppy is an erect, prickly annual herb native to America belonging to family lPapaveraceae'. The herb is a very common weed in the agricultural and wastelands, naturalized throughout India. The chemical composition of Argemone mexicana reportedly has alkaloids protopine, allocryptopine, berberine (Misra et al., 1961; Chelombitko et al., 1971), oxyhydrastinine (Hussain et al., 1983), cheilanthifoline, nor-sanguinarine (Pathak et al, 1985; Tripathi et al., 1999) coptisine, sanguinarine and chelerythrine (Abou-Donia et al., 1984). From Egyptian Argemone Mexicana norsanguinarine, 6-acetonyl dihydrosanguinarin, 6-acetonyl dihydrochelerythrin, reticuline, thalifoline, acetyl reframidine and muramine have been isolated (Nakkady et al, 1988). The plant reportedly also contains kokusoginene, a fiirano-quinoline alkaloid and 10-hydroxy-columbin, isolation of N-formyl anonaine, di-o-
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methylsyringaresinol and furanoid bisnorditerpene, also malabarolide from stems of the plant and N-methylpavine from the leaves and capsules has been reported (Sharma et al., 2000).
Different parts of Argemone mexicana have received considerable attention due to their reported medicinal uses. Milky juice of the fresh plant, seeds, and a mixed oil of fresh seeds and fresh roots have been used (IMM, 1982). Juice is diuretic, alterative, anodyne and hypnotic. Seeds are laxative, nauseant, emetic, expectorant and demulcent. Oil is a powerful alterative. Oil from the seeds is a drastic purgative, nauseant, expectorant, aperient and sedative.
The latex of the plant is used topically for conjunctivitis, eye irritation, pimples, acne, weals, pustules, skin diseases/irritation, wounds, ulcers, bruises, sores (Caceres et al., 1987). The latex is useful in dropsy, jaundice, skin diseases, leprosy, blisters, indolent ulcers, conjunctivitis, inflammations, burning sensation and malarial fever (IMPC, 1993), the latex is also used in the eye for treatment of cataract (Manandhar, 1993). Latex from the stem is useful in cleaning eyes (Singh, 1995) and latex from injured plants can be applied on cuts and open wounds as disinfectant (Bhattarai, 1993). External application of plant latex is used in treating infected teeth/dental caries. Fresh latex is used to treat warts, cold sores and blemishes on the lips and cataract (The Encyclopedia of Medicinal Plants, 1996). Juice from a broken stem is used to eliminate warts and ringworm and as a skin lotion (Halberstein, 1978).
Fresh root bruised and applied to the part stung by scorpions gives relief and powdered root is found useful in tapeworm and in chronic skin diseases (IMM, 1982; Singh, 1986). In the treatment of scabies, root paste prepared by grinding the root in water is taken orally and paste of the seeds is applied externally on the skin (Singh et al., 1996). The roots are useful in guinea-worm infestations, skin diseases, leprosy, pruritus, blennorrhagia, inflammations, all types of poisoning, constipation, flatulence, colic, malarial fever, vesicular calculus. The root is given as a decoction in bennorrhagia and applied on the affected part by grinding with onion to cure guinea worm affections (IMPC, 1993; IMP, 1933). Decoction of the root is given in gonorrhea, gleet, vascular calculus, tapeworm and skin diseases. It is also an eyewash, a mouth-wash and a lotion for inflammatory swelling (CRC Handbook of Ayurvedic Medicinal Plants, 1990).
The whole plant juice is reportedly useful in malarial fever, dropsy, jaundice, syphilis, gonorrhea, leprosy, and scabies (IMM, 1982; Singh, 1986). An infusion of the juice was regarded by early physicians as a diuretic and extensively used. The plant is used as antidote for snakebite (Singh V., Fitoterapia, 66, 425, 1995). The plant is reportedly diuretic,
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purgative, destroys worms, cures itching, leprosy, various skin diseases, leucoderma, inflammations, and bilious fevers, useful in strangury, an antidote to various poisons. It enriches blood, is a good expectorant and aphrodisiac (IMP, 1933) and is useful in colds and pneumonia (Oakes, 1958). Urinary infections can be treated with a decoction of whole plant of Argemone mexicana along with roots of Latania verschaffeltii and leaves and stem of Caesalpinia bonduc (Gurib-Fakim et al., 1996) or by using a tea made from boiling Argemone mexicana plant (Eldridge, 1975). The whole plant including roots, boiled and consumed in thick consistency for curing hepatitis and taken as a tea to cleanse body, improve fluid balance and regulate urination (Halberstein, 1978). A drink made by boiling Argemone mexicana with chips from Bursera simaruba is useful for high blood pressure (Asprey, 1955).
The leaves and stems contain protopine nitrate, berberine nitrate, ceryl alcohol, (3-sitosterol, an alcohol, carbohydrates, organic acids, potassium nitrate, calcium phosphate, calcium sulphate and amino acids (The Wealth of India, 1985). The presence of isorhamnetin-3-glucoside, |3-amyrin, cysteine and phenylalanine was determined in the Argemone mexicana leaves (Sukumar, 1984). The leaves are useful in cough, wounds, ulcers and skin diseases (IMPC, 1993). Juice of the leaves is given in dropsy, jaundice, skin diseases and gonorrhoea (Sahu, 1984). Externally leaf juice relieves blisters and heals excoriations, herpetic conditions and indolent ulcers (IMM, 1982). Juice of leaves used in fever, malaria and leprosy (Singh, 1986), decoction of leaves used in influenza and cough (Weniger et al., 1986). Anti-inflammatory activity of aqueous extract of leaves has been tested on carrageenin induced rat-paw oedema and results indicated a significant activity (Sukumar et al., 1984). Leaf latex and secretion/exudates of the stem is used for treating toothache and halitosis, a condition of having fetid breath (Flores et al., 1996). The pills made from pounded leaves and cumin seeds are used for stomach ache (Reddy et al., 1989). The aqueous extracts of leaves and flowers possess weak antibiotic property, whereas that of bark possesses antiviral property (The Wealth of India, 1985). Leaf juice mixed with that of Coleus aboinicus and honey is employed in gonorrhoea, fresh leaves and stems are used in chronic rheumatism (Sharmaetal., 2000).
Seeds are useful in cough and catarrhal affections of the throat and pulmonary mucous membrane and in pertussis and asthma. Smoke of the seeds relieves toothache, useful also in caries of the teeth (IMM, 1982). They have a distinct control over asthma, apparently from their combined actions of nauseant, emetic, expectorant and demulcent properties. The seed oil (argemone oil) is applied externally to ulcers, herpetic conditions and other skin
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diseases, also in headache. The oil is also useful as an alterative in syphilis and leprosy, and as an antidote to snake poison. Early European physicians in India used the seeds and seed oil as a remedy for dysentery and other intestinal affections (IMM, 1982; IMP, 1933; The Wealth of India, 1985). Yellow sap and seed powder is applied in eczema and other skin diseases, seed oil obtained by boiling powdered seeds applied on leucoderma and seed powder mixed with sap is used as ointment for eye diseases (Shah et al., 1985). Seeds are ground and soaked in water of hookah (hubble-bubble) and the extract is given to cure epileptic and other fits, powdered seeds of Argemone mexicana and Albizia lebbeck given in epileptic and hysterical fits orally as well as through inhalation (Sharma et al., 1992).
There has been much difference of opinion regarding the aperient action of the argemone oil but some believe that the oil in doses of 30 to 60 minims is a valuable remedy (Chopra's Indigenous drugs of India, 1982). In large quantities, the oil is unsafe to the extent of being poisonous. It contains two alkaloids, sanguinarine and dihydrosanguinarine. Ingestion of argemone oil causes high-tension glaucoma, dropsy, diarrhea, vomiting and anaemia (Chopra, 1930; Lai et al., 1939). The toxicity is attributed to the presence of alkaloid, sanguinarine. The toxicity of the oil is due to the combined effect of sanguinarine and 11-oxo-triacontanoic acid, the latter acts as a potentiating principle for the toxic activity of sanguinarine (Rukmini, 1975; Mahato et al., 1975).
The flowers are considered narcotic, expectorant and are useful for treating coughs and other chest conditions (The Wealth of India, 1985; The Encyclopedia of Medicinal Plants, 1996). They contain isorhamnetin, isorhamnetin-3-glucoside and isorhamnetin-3,7-diglucoside (Rahman et aL, 1962).
Although a variety of medicinal uses have been attributed to different parts of Argemone Mexicana plant, it must be emphasized that none of the prior art teaches use of the leaves of Argemone mexicana systemically for treatment of psoriasis. Thus the use of the extract prepared from only the leaves of Argemone mexicana for the treatment of psoriasis and the method of treatment by oral administration of the extract is novel and inventive.
The extract of the present invention is harvested from the leaves of the Argemone mexicana plant. The leaves are preferably collected as fresh healthy leaves from the plant. The leaves are cleaned with water, combined with water and optionally Cuminum cyminnm seeds. This combination is pulverized and blended at high speed in a mechanical mixer or a laboratory homogenizer until a dark green juice is obtained.
The herbal treatment composition may suitably be provided in the form of a liquid, a dry powder or powdered herbal concentrate, capsule, tablet and the like to a mammalian
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patient to be administered orally. For example, the herbal composition of the present invention may comprise an extract from the leaves of the Argemone mexicana at a concentration between about 2 and about 100 mg/g or ml.
The total amount of the composition prepared and the ratios of the ingredients in the mixture are somewhat variable. A typical mixture as a unit dose for oral administration would consist of approximately 10 to 12 leaves of about 8 to 10 inch in size and approximately 10 gm of Cuminum cyminum in approximately 50 ml of water.
In a preferred embodiment the composition of the present invention contains the desired ingredients as follows:
Extract from the leaves of 10-50 % wt
Argemone mexicana Extract from Cuminum cyminum seeds 60-90 % wt
The herbal treatment composition of the present invention has been found to have excellent results in treating psoriasis. The composition may suitably be administered to a mammalian patient orally as a liquid or powder concentrate to be added to a liquid, or in a pill, capsule or tablet form. For example the treatment composition of the present invention may be provided in a formulation containing extract from the leaves of Argemone mexicana at a concentration between about 2 and 100 mg/g or ml and it can be administered to a patient for example, in 1-3 gram dosages, once daily for three consecutive days in a week for a maximum period of about 12 to about 15 weeks.
The Psoriasis Area and Severity Index (PASI) score has persisted for long time as a handy simplification to describe the severity of psoriasis (Fredriksson et al., 1978). Clinically most investigators use the PASI score which takes into account the total body surface area of lesional skin, as well as the degree of erythema, scaling, and thickness to evaluate the efficacy of any given therapeutic protocol. The effectiveness of the composition according to present invention, for treatment of psoriasis was assessed by calculating PASI score during clinical tests every 2 weeks during the treatment regimen.
The following clinical data shows excellent results obtained by using the herbal treatment composition in accordance with the present invention to treat humans suffering from psoriasis. Example 1
This example sets forth a clinical study in connection with the skin disorder classified as psoriasis. A test population of 22 people who were classified as having chronic plaque type
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of psoriasis were included in a study. This group included 19 males and 3 females. The patients ranged in age from 25 to 75 years.
The protocol of treatment consisted of administering a liquid composition as unit
dosage as mentioned below:
Extract from the leaves of 10-12 leaves
Argemone mexicana
Water 50 ml
Cuminum cyminum seeds 10 gm
The composition was given orally once daily for three consecutive days in a week for a maximum period of about 12 to about 15 weeks. No other topical or internal treatment was applied or administered during the period of this testing. In the beginning of the treatment (initial PASI score) and during the treatment at the end of every two weeks, the PASI score of the patients was recorded. About 50 % of the patients showed 100 % reduction in PASI score, about 50 % of the patients showed 75 to 90 % reduction in the PASI score and 1 patient showed about 56 % reduction in the PASI score as compared to the initial PASI score.
A statistical analysis of the data recorded during clinical trials on the 22 patients was undertaken to evaluate the efficacy and tolerability of the composition of the invention and the method of treatment for psoriasis.
Table 1 represents the mean PASI score of the patients recorded at the beginning of every two weeks during the treatment regimen and Figure 1 shows a graphical representation of the same, where 'n1 stands for number of patients. A statistical reduction in the PASI score from 6.33 + 2.84 to 0.90 ± 1.27 has been observed, which is indicative that continuous administration of the herbal composition of the invention gives sustained reduction in the PASI score as treatment for psoriasis progresses. The disease-free state was observed in some patients 8 week onwards. Table 1- Actual PASI score (mean ± SD) during treatment duration

Treatment duration (week) PASI score (mean 1 SD) Number of patients (n)
0 6.33 + 2.84 22
2 4.79+2.16 22
4 3.53 11.72 22
6 2.5811.58 22
8 1.8611.43 20
10 1.35 + 0.91 17
12 0.94 10.82 13
14 0.92 10.90 6
15 0.90+1.27 2
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Table 2 represents reduction in PASI score at the end of each time interval, typically
two weeks, in comparison to basal PASI score at the beginning of each time interval and
figure 2 shows the graphical representation of the same. It is evident that response to the
treatment with the herbal composition was observed from second week onwards. The data
indicates that uninterrupted administration of the herbal composition according to the method
of treatment results in statistically significant rate of reduction in the PASI score. The PASI
scores declined in all the patients studied. The scores declined from basal value of 6.33±2.84
(mean+SD) to post-treatment levels of 0.90±1.27 (P<0.001).
Table 2- Comparison of PASI score (mean ± SD) at various time intervals during treatment duration

Treatment duration (week) (a) PASI score before (mean ± SD) (b) PASI score after (mean ± SD) (a)-(b) Number of patients (n)
0-2 6.33 ± 2.84 4.79 ±2.17 1.54 22
0-4 6.33 ± 2.84 3.53 ±1.72 2.80 22
0-6 6.33 ± 2.84 2.58 ±1.58 3.75 22
0-8 6.49 ±2.91 1.86 ±1.43 4.63 20
0-10 6.71 ±2.88 1.35 ±0.91 5.36 17
0-12 6.94 ± 2.28 0.94 ± 0.82 6.00 13
0-14 7.77 ± 2.23 0.92 ± 0.90 6.85 6
0-15 8.00 ± 0.42 0.90 ±1.27 7.1 2
To assess the tolerability of the treatment with the herbal composition according to the invention a graded system from poor to excellent was used for analyzing the response from the patients during clinical trials as shown in Table 3 and graphically represented in Figure 3. The result indicates that there was an excellent toleration of the herbal composition in the treatment of psoriasis. No serious side effects were observed in any of the patients and no symptom rebounding was observed during or after the treatment. There were no reports of disease rebound, a condition where a patient's psoriasis becomes substantially more severe than at baseline once treatment is completed.
Table 3- Tolerability of the herbal composition

Number of patients (%)
Grade/Week 2 (n=22) 4 (n=22) 6
(n=22) 8 (n=21) 10
(n=18) 12 (n=13) 14
(n=6) 15 (n=3)
Poor 0 0 0 0 0 0 0 0
Fair 14 18 32 38 33 31 33 0
Good 73 77 68 62 67 62 _J 33 100
Excellent 14 5 0 0 0 8 33 0
where n represents number of patients.
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Further the pathological tests for monitoring the hematological, hepatic and renal functions showed no abnormal changes from the normal permissible ranges. In few cases subclinical changes were observed which were reversible and reversed back to normal value on completion of treatment.
Furthermore, the tests made up to the present time on animals have not shown any particular toxicity for the composition according to the invention.
This invention may be embodied in other forms or carried out in other ways without departing from the spirit or essential characteristics thereof. The present embodiment is therefore to be considered as in all respects illustrative and not restrictive. References
1. Kruger G. G., "Psoriasis: Current Concepts of its Etiology and Pathogenesis", The Year Book of Dermatology, 1981.
2. Beutner E. H., "Autoimmunity in Psoriasis", CRC Press, 1982.
3. British "National Pormulary (BNF), "No. 41, March 2001.
4. Stern R. S. and Laird N., Cancer, 73, 2759, 1994.
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6. Feldman S. R., American Academy of Dermatology, August 2000.
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Pharmazie, 40, 202, 1985.
12. Tripathi P. N., Tripathi M., Pandey V. B. and Singh D., Orient. J. Chem., 15, 185, 1999.
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16. Indian Materia Medica (IMM), Nadkarni K. M., 3rd Edition, 133, Popular Prakashan, 1982.
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17. Caceres A., Giron L. M., Alvarado S. R. and Torres M. F., J. Ethnopharmacol., 20, 223, 1987.
18. Indian Medicinal Plants (IMP), Volume I, 2nd Edition, Kirtikar K. R. and Basu-B. D., Ed. Blatter E., Caius J. F. and Mhaskar K. S., Published by Basu L. M.s 1933.
19. Manandhar N. P., Fitoterapia, 64, 266, 1993.
20. Singh V., Fitoterapia, 66, 425, 1995.
21. Bhattarai N. K., Fitoterapia, 64, 483, 1993.
22. The Encyclopedia of Medicinal Plants- A Practical Reference Guide to over 550 Key Herbs and their Medicinal Uses, Kindersley D. and Chevallier A, Dorling Kinderslay Limited, London, 1996.
23. Halberstein R. A. and Saunders A. B., Cul. Med. Psychiat, 2, 177, 1978.
24. Singh Y. N., J. Ethnopharmacol., 15, 57,1986.
25. Singh V. K., Ali Z. A., Zaidi S. T. H. and Siddiqui M. K., Fitoterapia, 67, 129, 1996.
26. Indian Medicinal Plants- A Compendium of 500 Species (TMPC), "Volume T, VarierP. S., Orient Longman Limited, 1993.
27. CRC Handbook of Ayurvedic Medicinal Plants, Kapoor L. D., CRC Press, Inc. Boca Raton, Florida, 1990.
28. Oakes A. J. and Morris M. P., Bull. Hist. Med., 32, 164, 1958.
29. Gurib-Fakim A., Sweraj M. D., Gueho J. and Dulloo E., Int. J. Pharmacog., 34, 2, 1996.
30. Eldridge J., Econ. Bot, 29, 307, 1975.
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35. Weniger B.s Rouzier M., Daguilh R, Henrys D., Henrys J. H. and Anton R., J. Ethnopharmacol., 17, 13, 1986.
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40. Chopra's Indigenous drugs of India, Chopra R. N., Chopra I. C, Handa K. L. and Kapur L. D., 2nd Edition, 283, Academic Publishers, New Delhi, 1982.
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43.RukminiC.,J. Am. OilChem. Soc, 52, 171, 1975.
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We claim
1. An oral composition for the treatment of psoriasis comprising an effective amount of extract from leaves of Argemone mexicana plant
2. A composition as claimed in claim 1 wherein it farther includes a pharmaceutically acceptable carrier or vehicle.
3. The composition as recited in claim 1 further comprising Cuminum cyminum seeds.
4. An oral pharmaceutical composition for the treatment of psoriasis comprising of from 10 to 50% by wt of an extract from leaves of Argemone mexicana plant and from 60 to 90% by wt of an extract from seeds of Cuminum cyminum, the balance if any, consisting of pharmaceutically acceptable carrier, vehicle or excipient.
5. A composition as claimed in any preceding claim in the form of a powder.
6. A composition as claimed in claim 5 wherein said powder is in a gelatin capsule.
7. A composition as claimed in any one of claims 1 to 3 wherein it is in the form of a solution.
8. A composition as claimed in any one of claims Ito 3 wherein it is in the form of a herbal concentrate.
9. A method for the manufacture of an oral composition for the treatment of psoriasis comprising washing leaves of Argemone mexicana, pulverizing said leaves and blending the pulverized leaves at high speed in a mechanical mixer or a homogenizer until a dark green juice is obtained.
10. A method as claimed in claim 9 wherein said pulverizing and/or blending is carried out in the presence of water.
11. A method as claimed in claims 9 or 10, wherein said leaves of Argemone mexicana are pulverized and /or blended in the presence of seeds of Cuminum cyminum.
12. A method as claimed in claim 11 wherein the amount of said extract from the leaves of Argemone mexicana is from 10 to 50 % by wt and the amount of said extract from the seeds of Cuminum cyminum is from 60 to 90 % by wt and the balance if any consists of pharmaceutically acceptable vehicle, excipient or carrier.
13. A method for treating psoriasis in a mammal comprising the steps of: administering orally to said mammal affected by psoriasis, an effective amount of the extract from the leaves of Argemone mexicana. .
14. The method as claimed in claim 13, wherein the administering step comprises administering the extract consecutively for 3 days a week for a duration sufficient to alleviate the symptoms of psoriasis.
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15. The method as claimed in claim 14 wherein the duration comprises a range of a maximum period of about 12 to about 15 weeks.
16. The method as claimed in claim 13 wherein the extract from the leaves of the plant is obtained by pulverizing the leaves with water.
17. The method according to claim 13 wherein the extract from the leaves of Argemone mexicana is present in a concentration of about 2 to about 100 mg per unit composition.
18. A method according to claim 13, wherein said extract is a liquid.
19. A method according to claim 13, wherein said extract is a dry powder.
20. A method for treating psoriasis comprising the steps of:
1) providing an herbal composition comprising
Extract from the leaves of 10-50 % wt
Argemone mexicana Extract from Cuminum cyminum seeds 60-90 % wt
2) administering an effective amount of said composition to a subject in need thereof.
21. An oral composition for the treatment of psoriasis substantially as described hereinbefore and with reference to the foregoing examples and accompanying drawings.
22. A method for the manufacture of an oral composition for the treatment of psoriasis substantially as described hereinbefore and with reference to the foregoing examples and accompanying drawings.
23. A method for treating psoriasis in a mammal substantially as described hereinbefore and with reference to the foregoing examples and accompanying drawings.
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Dated this the 9th dayof January 2002.