EFFECT OF AYURVEDIC MANAGEMENT IN THE MANAGEMENT OF PSORIASIS

Phase 2/3

Not yet recruiting

Conditions: Generalized pustular psoriasis,

Registration Number: CTRI/2020/01/022844

Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary: Psoriasis is a chronic, noncommunicable, painful, disfiguring and disabling disease for which there is no cure and with great negative impact on patientsâ€™ quality of life (QoL). It can occur at any age, and is most common in the age group 50â€“69 . The reported prevalence of psoriasis in countries ranges between 0.09% (2) and 11.4% , making psoriasis a serious global problem. The etiology of psoriasis remains unclear, although there is evidence for genetic predisposition . The role of the immune system in psoriasis causation is also a major topic of research. Although there is a suggestion that psoriasis could be an autoimmune disease, no autoantigen that could be responsible has been defined yet. Psoriasis can also be provoked by external and internal triggers, including mild trauma, sunburn, infections, systemic drugs and stress.

Psoriasis causes great physical, emotional and social burden .QoL, in general, is often significantly impaired . Disfiguration, disability and marked loss of productivity are common challenges for people with psoriasis. Treatment of psoriasis is still based on controlling the symptoms.

Psoriasis is categorized in Ayurveda as a vata-kapha disease. There are many classical Ayurveda formulations indicated for skin diseases and Psoriasis in particular . The Ayurvedic Pharmacopeia of India has laid standards of Ayurvedic formulations appeared in Ayurvedic Formulary of India. Oral administration of PanchatiktaGhrita and local application of NalpamaradiTailaare the formulations commonly used by Ayurvedic physicians in the management of Psoriasis and the pharmacopeial standards are available for both these formulation.

Considering this, the Council has undertaken the validation of these two formulations to generate the evidence of their clinical efficacy and safety in the management of Psoriasis under validation of classical ayurvedic formulations programme under Annual action Plan 2017-18.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Patients of either sex with age between 18 and 60 years.
2.Known cases of psoriasis, without psoriatic arthropathy, Exhibiting psoriatic triad â€“ a.Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion.
b.Under the scales there appears a pinkish moist tender skin.
c.With the scraping of the moist skin there appear tiny blood droplets (Auspitzâ€™s sign) 3.Patients suffering from psoriasis with less than 50 % of the body surface involvement.
4.Disease duration between 3 months to 5 years.
5.V.D.R.L./ HIV/Hepatitis negative.
6.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, and 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, cardiovascular disease Tuberculosis, Psycho.
Neuro-endocrinal disorders, etc.). 6.Patients on medication with corticosteroids, phototherapy, biologics,antidepressants any other drugs that may have an influence on the outcome of the study. 7.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.4 mg/dl) oruncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or AIDS or STD or other concurrent severe disease. 8.Alcoholics and/or drug abusers. 9.H/o hypersensitivity to the trial drug or any of its ingredients. 10.Patients who have completed participation in any other clinical trial during the past six months. 11.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 Area and Severity Index(PASI) score	84 day

Secondary Outcome Measures

Name	Time	Method
Changes in the clinical Sign & symptoms ofPsoriasis	Change in Dermatology life Quality Index (DLQI) Questionnaire

Trial Locations

Locations (2): Regional Ayurveda Research Institute for Skin disorders Vijaywada
🇮🇳
patient, India
Regional Ayurveda Research Institute for Skin disorders, Ahmedabad
🇮🇳
Ahmadabad, GUJARAT, India
Regional Ayurveda Research Institute for Skin disorders Vijaywada
🇮🇳patient, India
DrAnumol K
Principal investigator
dranumolk@gmail.com