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NCT07841314
Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis
Conditions: Chronic Plaque Psoriasis, Plaque Psoriasis, Psoriasis, Taqashshur al Jild
Sex: All
Ages: 20 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 54
Sponsor: National Institute of Unani Medicine, Bengaluru
Location: National Institute of Unani Medicine Bangalore Karnataka
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
Eligibility Criteria
Inclusion Criteria:
* Subjects of all gender identities aged 20-60 years
* k/c/o Subjects suffering with chronic Plaque Psoriasis
* New subjects clinically and histopathologically diagnosed with Plaque Psoriasis
* Subjects having PASI score: 3-20 and SPI-s \20 and SPI-severe (SPI-s \>21)
* Subjects with any superadded infected Psoriasis
* Subjects having Psoriatic Arthritis and ocular psoriasis.
* Subjects suffering from other diseases and on concomitant therapy and drugs that can aggravate Psoriasis like Beta blockers, Calcium Channel Blockers or Lithium.
* Subjects with h/o alcohol \& drug abuse
* Pregnant and lactating women
* Subjects with other inflammatory skin conditions in the treatment area (eg.tinea corporis, contact dermatitis, atopic dermatitis)
* Subjects taking or requiring corticosteroids
* K/c/o subjects with Current or past history of hepatic or renal insufficiency
Source: ClinicalTrials.gov (NCT07841314). StuddyBuddy aggregates publicly available trial information.