Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis

Condition(s) studied

Investigational drug(s) / intervention(s)

Marham Asfedaj: Marham Asfedaj (Unani ointment) applied locally twice daily for 60 days

Mundij wa Mushil Sawda (Unani Oral decoction): Mundij wa mushil Sawda (Unani Oral decoction) 50 ml taken orally once morning daily before food for 40 days

Coal tar 1% & Salicylic acid 3 % solution: Coal tar 1% \& Salicylic acid 3% Solution topical application twice daily for 60 days

Study 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

Primary outcome measure(s)

• Psoriasis Area Severity Index — PASI will be assessed every 2 weeks i,e at Day 0 (Baseline), Day 15, Day 30, Day 45, day 60 and 1 month after completion of treatment (day 90)
  The Psoriasis Area and Severity Index (PASI) is a validated clinical tool used to assess the severity and extent of psoriasis. It combines the evaluation of the degree of erythema (redness), induration (thickness), and desquamation (scaling) with the percentage of affected body surface area across four anatomical regions: head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%). Each region is scored independently on: * Severity of three clinical signs (0 = none to 4 = maximum severity) * Area involvement (0 = 0%, 1 = \<10%, up to 6 = 90-100%) The PASI score is calculated by summing the severity scores, multiplying by the area score, and then weighting according to the proportion of body surface area represented by each region.

Trial sites (1)