Clinical Research Directory

Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis

Sponsor: National Institute of Unani Medicine, Bengaluru

Summary

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

Official title: Comparative Study on Marham-e-Asfedaj Versus Coal Tar 1% and Salicylic Acid 3% Solution Along With Mundij wa Mushil-i Sawdā in Taqashshur-al- Jild (Plaque Psoriasis) - A Randomized Open Labelled, Split Body Active Control Clinical Trial

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