Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Minor Study First Submitted
This trial tests whether a Unani ointment (Marham-e-Asfedaj) plus an oral Unani formulation (Mundij wa Mushil-i Sawdā) works better than a active treatment (salicylic acid 3% solution, also combined with Mundij wa Mushil-i Sawdā) for treating chronic plaque psoriasis in adults. It will also check whether Marham-e-Asfedaj is safe to use. Main question: Does adding Marham-e-Asfedaj to Mundij wa Mushil-i Sawdā work better than adding salicylic acid 3% solution to Mundij wa Mushil-i Sawdā? What participants will do: * Take a Unani oral medicine (Mundij wa Mushil-i Sawdā) once a day for the first 40 days * Have two matching psoriasis patches treated differently - one side of the body (chosen at random) gets a Unani ointment (Marham-i-Asfedaj), and the other side gets a standard treatment (coal tar 1% + salicylic acid 3%). Both are applied twice daily from day 1 to day 60 * Give blood samples to check general health, liver, and kidney function, and have a small skin sample taken (biopsy) at the start (day 0) and end of treatment to see how the histological morphology has changed * Come in for check-ups on days 0, 15, 30, 45, and 60, with a final follow-up visit one month after treatment ends * Not use any other psoriasis treatment during the study, so the results reflect only the study treatments Trial duration: 60 days of treatment, plus a follow-up visit 1 month later - so each participant is involved for about 3 months total. What the study is measuring (outcome measures): * Severity of psoriasis, tracked using two standard scoring tools (PASI and SPI), checked five times during treatment * Quality of life, using a standard skin-disease questionnaire (DLQI), checked at the same visits * Skin changes under the microscope, comparing biopsy samples from before and after treatment * Safety, through blood tests checking overall health, liver, and kidney function
Trial Details
NCT Number NCT07841314
Lead Sponsor National Institute of Unani Medicine, Bengaluru
Conditions
(from sponsor)
Chronic Plaque Psoriasis, Plaque Psoriasis, Psoriasis, Taqashshur al Jild
Related terms Psoriasis
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov