A Clinical trial and analysis of immune response indicators to explore the role of Homoeopathy in patients of Psoriasis
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2021/06/034331
- Lead Sponsor
- Central Council for Research in Homoeopathy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1At least 3month history of Psoriasis
2All types of psoriasis
3No drug dependence
4No medication for psoriasis (both oral and local) for at least 6 weeks in succession till date
•Mild/moderate/Severe cases as per PASI Score
•Willing to give informed consent
•Ongoing treatment/medication for Psoriasis, of any medical discipline both oral and/ local or phototherapy.
•Evidence of skin conditions (i.e eczema, lichen planus, teania) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasisPregnant ladies or breast-feeding women.
•On treatment for any systemic infection , inflammatory, autoimmune disorder, malignancy, or any type of drug dependence like diabetes, hypertension, thyroid medications or any other disease like asthma, allergic disease etc
•Known kidney function disorder.
•Persons taking calcium, vitamin D supplements or vitamin D-like medicines ??
•Very severe cases as per PASI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Serum levels of Th17 derived cytokines (IL-17A, IL-17F, IL-17A/F and IL-22), IL-33 at day 0, 180 and 360 during course of homoeopathic treatment for Psoriasis using ELISA based on PASI scoring. <br/ ><br>2. PASI score at day 0, 180, 360 during course of homoeopathic treatment for Psoriasis. <br/ ><br>Timepoint: 1. Serum levels of Th17 derived cytokines (IL-17A, IL-17F, IL-17A/F and IL-22), IL-33 at day 0, 180 and 360 during course of homoeopathic treatment for Psoriasis using ELISA. <br/ ><br>2. PASI score at day 0, 180, 360 during course of homoeopathic treatment for Psoriasis. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.m-RNA expression of Th17 derived cytokines, IL-33 along with its receptor sST2 in PBMCs of patients at day 0,180 and day 360 using Real Time PCR. <br/ ><br>2.Quality of life by change in Dermatology Life quality Index at Day 0, 180, 360. <br/ ><br>3.Proportion (%) of enrolled participants achieving a PASI improvement of 50% using PASI 50 at the end of 360 days. <br/ ><br>Timepoint: Period of StudyAchievable Targets <br/ ><br>0-6 monthsEnrolment and follow up <br/ ><br>Upto 18 monthsFollow up the cases <br/ ><br>18-24 monthsData compilation & analysis ;manuscript preparation of the study <br/ ><br>Regular clinical assessments as per case requirements <br/ ><br>