"Clinical trial of some Ayurvedic drugs and special diets in the management of Psoriasis"

Phase 2/3

Recruiting

• Conditions: Psoriasis

• Registration Number: CTRI/2015/01/005426
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

The ancient acharyas have described this disorder as one of the mahagada which is seen in the skin. Kushta is divided into seven types of Mahakushta and eleven types of Kshudrakushta according to severity and predominance of doshas in Ayurveda. Psoriasis (Kitibha kushta) is a type of kshudra kushta which is occurs due to the vitiation of three doshas and dearangement in Twak (skin) Rakta (Blood), Mamsa (Muscle tissue) and Ambu (body fluids) Psoriasis is a chronic skin disease characterized by red patches on the skin, often accompanied by silvery-white scales of dead skin cells. Psoriasis is not contagious. It cannot be spread by touch from person to person. The ratio of male to female (2.46:1) was very high which could not be clearly accounted for. Highest incidence was noted in the age group of 20-39 years and the mean age of onset in males and females was comparable (Okhandiar et al. collected a comprehensive data from various medical colleges).  Psoriasis is believed to be an autoimmune disease, meaning the body’s defense system attacks healthy cells in the body. This creates skin cells that mature and die in less than a week, which is extremely rapid considering normal skill cells mature and replace dead ones usually in a month’s time. Experts believe that psoriasis occurs when the immune system overreacts, causing inflammation and flaking of skin. In some cases, psoriasis runs in families. Researchers are studying large families affected by psoriasis to find out how it is passed from parents to their children and what might trigger the condition. People with psoriasis often notice times when their skin gets worse. Things that can cause these flare-ups include a cold and dry climate, infections, stress, and dry skin. Also, certain medicines, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and medicines used to treat high blood pressure or certain mental illnesses may trigger an outbreak or make your psoriasis worse. Smoking, especially in women, makes you more likely to get psoriasis and can make it worse if you already have it. Symptoms of psoriasis appear in different ways. Psoriasis can be mild, with small areas of rash. When psoriasis is moderate or severe, the skin gets inflamed with raised red areas topped with loose, silvery, scaling skin. If psoriasis is severe, the skin becomes itchy and tender. And sometimes large patches form and may be uncomfortable. The patches can join together and cover large areas of skin, such as the entire back. In some people, psoriasis causes joints to become swollen, tender, and painful. This is called psoriatic arthritis (say "sor-ee-AT-ik ar-THRY-tus"). This arthritis can also affect the fingernails and toenails, causing the nails to pit, change color, and separate from the nail bed. Dead skin may build up under the nails. Symptoms often disappear (go into remission), even without treatment, and then return (flare up). Currently there is no cure for psoriasis. But many types of treatment are available, including products applied to the skin, phototherapy, and oral medicines, which can help control psoriasis. Most cases are mild and can be treated with skin products. In some cases, psoriasis can be hard to treat if it is severe and widespread. Most psoriasis returns, even mild forms. Shodhana and Shamana chikitsa is mentioned in Ayurveda for the management of Kushta. Shodhana chikitsa is based on Panchkarma therapy where shaman is included with oral medication and local application. Panchtiktaguggulu Ghrita and Brihanmarichadya Taila is also described for the treatment of Kushta (AFI Part-I, 6:27, page 121 & Vol.-II 8:9, Page 147) in the Ayurvedic classical texts (Ashtang Hridaya, Chikitsa adhyay 21/57-60 & Yogratnakar vatrakta rogadhikar tail prakaran 1-5) The aim of this study is to evaluate of efficacy of Panchtiktaguggulu Ghrita and Brihanmarichadya Taila in the management of Psoriasis (Kitibha kushta). Project will be conducted in two groups first group is drug intervention and second group is drug intervention with diet restriction.   • Study design - Open comparative study. • Duration of therapy – 12 weeks per subject • Duration of the study – Two years • Sample size - 60 subjects in each group Efficacy of the medicines will be assessed according to sign & symptoms of both systems. Necessary pathological, biochemistry and other investigations will be conducted for the standardization of this project. The observations and discussion will be made according to statistical analysis on different parameters.

Composition of Panchtikta Guggulu Ghrita (A.F. I. Part-1, 6:27): 1. Nimba tvak (Azadirachta indica) 2. Amrta (Guduchi) (Tinospora cordifolia) 3. Vasa (Adhatoda vasica) 4. Patola (Trichosanthes dioica) 5. Kantkari (Solanum xanthocarpum) 6. Jala decoction reduced to: Water 7. Goghrita (Clarified butter from Cow’s milk) 8. Patha (Cissampelos Pareira) 9. Vidanga (Embelia ribes) 10. Devadaru (Cedrus deodara) 11. Gajapippali (Scindapsus fficinalis) 12. Yava kshara (Yava) (Hordeum vulgare) 13. Sarjikakshara  14. Nagara (Sunthi) (Zingiber officinale) 15. Nisha (Haridrd) (Curcuma longa) 16. Misreya (Foeniculum vulgare) 17. Chavya (Piper retrofractum) 18. Kushtha (Saussurea lappa) 19. Tejovati (Zanthoxylum alatum) 20. Maricha (Piper nigrum) 21. Vatsaka (Kulaja) (Holarrhena antidysenterica) 22. Dipyaka (Yavani) (Trachyspermum ammi.) 23, Agni (Chitraka) (Plumbago zeylanica) 24. Rohini (Katuka) (Picrorrhiza kurrooa) 25, Aruskara (Bhallataka-Suddha) (Semecarpus anacardium) 26. Vacha (Acorus calamus) 27. Pippali (Piper longum) 28. Yukta (Rasna) (Pluchea lanceolata) 29. Manjishtha (Rubia cordifolia) 30. Ativisha (Aconitum heterophyllum) 31. Visha (Ativisha bheda) (Aconitum palmatum) 32. Yavani (Tachyspermum amrni) 33. Guggulu (Suddha) (Commiphora wightii)

Composition Brhanmarichadya Taila (AFI-Part-II, 8:9): 1. Marich  (Piper nigrum) 2. Trivrtta (Operaculina turpethum) 3. Danti (Ballospermum montanum) 4. Arkakshira (Arka) (Calotropic gigantea) 5. Gornaya Rasa (Bio- product) 6. Devadaru (Cedrus deodara) 7. Haridra (Curcuma longa) 8. Daruharidra (Berberis aristata) 9. Jatamansi (Nardostechys jatamnsi) 10. Kushtha (Saussurea lappa) 11. Chandana (Shvet) (Santalum album) 12. Vishala (Trichosanthes palmata) 13. Karavira (Nerium indicum) 14. Haritala (Mineral product) 15. Manjishtha (Rubia cordifolia) 16. Chitraka (Plumbago zeylanica) 17. Langali (Gloriosa superba) 18. Vidanga (Embelia ribes) 19. Chakrarmarda (Cassia tora) 20. Sirisa (Albizia lebbeok) 21. Kutaja (Holarrhena antidysenterica) 22. Nimba (Azadirachta indica) 23. Saptaparna (Alustonia ascularis) 24. Amrta (Guduchi) (Tinospora cordifolia) 25. Snuthi (Zingiber officinale) 26. Amaltas (Aragvadha) (Cassia Fistula) 27. Naktamala (Karanja) (Pongamia pinnata) 28. Khadira (Acasia catechu) 29. Pippali (Piper longum) 30. Vacha (Acorus calamus) 31. Jyotismati (Celastrus paniculatus) 32. Visha (Suddha vatsanabha) (Aconitum palmatum) 33. Katu taila (sarsapa) (Brassica campestris) 34. Gomutra (Bio- product)

Pathya - Apathya (Classical Ayurvedic Prescriptions for Common Diseases – Published by C.C.R.A.S., New Delhi, Page no. 99) Pathya: Cereals -Wheat & Barley – As in the form of Bread (Chapati, Daliya). Pulses- Green gram (Munga), Masura - As in the form of dala and as mixer with wheat & barley. Fruits & vegetables- Nimba haridra, Patola, Nutmeg (jayaphala), Phalasa, Bottle Gourd (Louki), Ridge Gourd (Tori), Pointed Gourd  (Parwal), Amaranth (Choulai), Cucumber (Kakadi) as vegetables & Haritak varga as spices) Apple & Papaya,Pomengranate. Milk Products - Cow milk, Goat milk and Go ghrita as part of diet. Others - Dry and bitter taste food substances, khadira, dry ginger (Shunthi), Black pepper, Long papper, old clarified butter, Honey. (Haritak Varga as spices) Life style - Bathing, light exercise (alpa vyayama), massage (Udvartana with green gram powder (aata) Apathya: Cereals- Preparations of newly harvested cereals (navanna) Rice, Wheat, Barley, jiggery (Guda) and Sugar. Pulses- Mass, split red gram (tuvar dal), Black gram, Rajama. Fruits & vegetables- Garlic, Radish, Bitter gourd, Pumpkin, and raw Onion. Excessive use of spices.All kinds of citrus fruits & Bananas. Milk Products - Curd, Butter milk and Cheese. Others - Incompatible food (viruddha ahara), food with heavy, cold and unctuous properties (oily food), food causing burning sensation and obstructing the channels, curd, fish, sesame (tila), salt, sour substances, black gram, jiggery, lisora, makoya, milk (all kind of fast food.) Life style - Day sleeping, suppression of natural urges, mental stress, excessive exercise. (Divaswapna, Vegawrodha, Ratri jagrana).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-03
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients of either sex with age between 18 and 60 years.
• Known cases of psoriasis, without psoriatic arthropathy, Exhibiting psoriatic triad – a.
• Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion.
• Under the scales there appears a pinkish moist tender skin.
• Patients suffering from psoriasis with less than 50 % of the body surface involvement.
• Disease duration between 3 months to 5 years.
• V.D.R.L. / HIV/Hepatitis negative.
• Positive histopathological finding.(Skin-biopsy) 7.
• Willing to participate in the study.

Exclusion Criteria

• 1. Generalized skin lesions, Herpes simplex, Herpes zoster, Scabies, Acne, Urticaria, Immunological medicated skin diseases like Pempigus vulgaris, Dermatitis ,herpetiformis, Guttate, Pustular, Lupus erythematous, Psoriatic arthropathy etc. 2. Patients with poorly controlled Hypertension (Blood pressure more than 160/100mm of Hg). 3. Pregnant or lactating women. 4. Patient with uncontrolled Diabetes Mellitus (Blood sugar fasting more than 250 mg/dl). 5. Patient suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho – Neuro.
• endocrinal disorders, etc.). 6. Patient’s suffering/Past history of Heart disease, serious hepatic disorders, Severe Pulmonary Dysfunction, Renal Disorders etc. 7. Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study. 8. Patients with concurrent serious hepatic disorder or renal disorders, AIDS, STD etc. 9. Alcoholics and/or drug abusers. 10. H/o hypersensitivity to the trial drug or any of its ingredients. 11. Patients who have completed participation in any other clinical trial during the past six months. 12. Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Changes in Psoriasis Severity score.	Two Years

Secondary Outcome Measures

Name	Time	Method
• Changes in the clinical Sign & symptoms of Psoriasis.	• Change in Dermatology life Quality Index (DLQI) Questionnaire.

Trial Locations

Locations (1)

National Research Institute for Ayurveda - Siddha Human Resource Development , Gwalior; 🇮🇳 Gwalior, MADHYA PRADESH, India

National Research Institute for Ayurveda - Siddha Human Resource Development , Gwalior

🇮🇳Gwalior, MADHYA PRADESH, India

Dr Om Prakash

Principal investigator

9406581637

oprakash749@gmail.com