Evaluation of changes in the Gut Microbiome following virechana karma (therapeutic purgation therapy) in patients of Chronic Plaque Psoriasis.
Phase 3
- Conditions
- Health Condition 1: L400- Psoriasis vulgaris
- Registration Number
- CTRI/2023/05/052326
- Lead Sponsor
- Ayurvedic and Unani Tibbia college and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with Chronic Plaque Psoriasis, having the clinical features like - well defined indurated erythematous areas of circular shape of various sizes with silvery scales, itching etc.
Exclusion Criteria
1. Patients who are contraindicated for virechana karma such as – Loss of bowel control, Atisara (diarrhea), Pregnant women and Lactating mothers.
2. Patients suffering from Exfoliative dermatitis and Psoriatic arthritis.
3. Patients who have taken probiotic supplements and antibiotics in the past 6 weeks.
4. Patients having cardiac and renal disorders.
5. Patients taking any form of allopathic anti-hypertensive medicine and/or allopathic anti-diabetic medications.
6. Patients requiring emergency treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Chronic Plaque Psoriasis patients showing change in the V3-V4 region of 16srRNA gene post virechana karma.Timepoint: 24 hrs post completion of 5 days of samsarjana krama
- Secondary Outcome Measures
Name Time Method 1. The proportion of individuals showing difference in gut bacterial diversity depending on their baseline dietary habit and staple food.Timepoint: 24 hrs post completion of 5 days of samsarjana krama;2. Proportion of Chronic Plaque Psoriasis patients showing improvement in Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI) and Itch Numerical Rating Scale (Itch NRS) post virechana karma.Timepoint: DLQI – post completion of samsarjana karma <br/ ><br>PASI – post completion of samsarjana karma <br/ ><br>Itch NRS - every day until samsarjana krama is completed <br/ ><br>