A clinical study to evaluate the efficacy and safety of the Vamana karma followed with two Rasayanas Takradhara and Rasaoushadi in treatment of psoriasis.

Phase 3

Recruiting

• Conditions: Psoriasis (Kitibha)

• Registration Number: CTRI/2016/02/006631
• Lead Sponsor: Central council for Research in Ayurvedic sciences CCRAS

Brief Summary

This is a part of Intra Mural Clinical Research Programme of the council for Research in Ayurvedic Sciences (CCRAS), Department of AYUSH, Ministry and Health and Family Welfare, Govt. Of India, incorporating vamanakarma as samsodhana karma Followed by Takradhara and rasayana chikitsa with yasada Bhasma with a view to scientifically document the clinical efficacy and safety of the said Ayurvedic formulations that have been in use since thousands of years for the management of Kitibha (psoriasis).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-27
• Last Update Posted: 2016-01-19

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 110

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 – I.Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion II.Under the scales there appears a pinkish moist tender skin III.With the scarping of the moist skin there appear tiny blood droplets (Auspitz’s sign) 3.Patients suffering from psoriasis with less than 50 % of the body surface involvement 4.Patients having less than 10 years duration of disease 5.Positive histopathological finding (Skin-biopsy.

Exclusion Criteria

• 1.Age below 18 years and above 60 years 2.Patients with other forms of Psoriasis like Guttate or Pustular or Erythrodermic or inverse.
• 3.Patients suffering from very severe psoriasis with more than 50% of the body surface involvement 4.Patients having chronic disease i.e. more than 10 years duration 5.Patients who are not ready for IPD admission or Vamana Karma or follow up as specified 6.Patients with Psoriatic arthropathy 7.Patients with poorly controlled Hypertension ( more than 160/100 mmHg) 8.Patients with poorly controlled Diabetes Mellitus having Hb A1C of greater than 7.5% 9.Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study.
• 10.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
• 11.Symptomatic patient with clinical evidence of Heart failure.
• 12.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) more than 2 times upper normal limit) or Renal Disorders (defined as S.
• Creatinine more than 1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
• 13.Alcoholics and/or drug abusers 14.H/o hypersensitivity to any of the trial drugs or their ingredients 15.Pregnant/lactating woman.
• 16.Patients who have completed participation in any other clinical trial during the past six months.
• 17.Other conditions which are of contraindications for Vamana karma 18.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
Relief in signs and symptoms (change in baseline in Plaque psoriasis) Reduction in psoriasis area and severity index (PASI) Score, PASI 50 (50% improvement in PASI Score)	At Baseline, 24th day, 45th day and 66th day

Secondary Outcome Measures

Name	Time	Method
Relief in signs and symptoms (change in baseline in plaque psoriasis) of PASI 25.	Improvement in Dermatology Life Quality Index (DLQI) questionnaire.

Trial Locations

Locations (2)

NRIADD Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

NRIP Cheruthuruthy; 🇮🇳 Thrissur, KERALA, India

NRIADD Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Dr Achintya Mitra

Principal investigator

9836727927

achintyamitra1@gmail.com