A Phase 2 interventional study of Marham Asfedaj and Mundij wa Mushil Sawda (Unani Oral decoction) in Chronic Plaque Psoriasis, Plaque Psoriasis and Psoriasis, sponsored by National Institute of Unani Medicine, Bengaluru. Not yet recruiting at 1 site in India. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by National Institute of Unani Medicine, Bengaluru · Phase 2, Interventional, and Treatment
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:
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):
After initial screening, patients will be recruited based on specific selection criteria, which include individuals aged between 20 and 60 years diagnosed with Plaque Psoriasis. Subjects exhibiting severe plaque psoriasis characterized by a PASI score greater than 20 and a severe Simplified Psoriasis Index (SPI), or those with infected psoriasis, psoriatic arthritis, ocular psoriasis, metabolic disorders, concomitant therapies, or other inflammatory skin conditions will be excluded from the study. Eligible patients, upon providing informed consent, will receive Mundij wa Mushil-i Sawdā,10gm orally once daily for the first 40 days. For topical treatment, the psoriatic lesions will be randomized-such as by body laterality (right vs. left)-to receive either Marham-i-Asfedaj or a combination of coal tar 1% and salicylic acid 3% solution, applied twice daily in a quantity sufficient (q.s.) from day 1 to day 60. Participants will undergo a series of investigations including hemogram, liver function tests (ALT, AST, ALP), renal function tests (S. urea, S. creatinine), and skin biopsy (punch biopsy) for histopathological evaluation wherein the morphology of the sample will be studied both before and after the treatment, specifically on day 0 and day 60. Clinical assessments using PASI, SPI, and DLQI will be conducted on days 0, 15, 30, 45, and 60, followed by a post-treatment evaluation one month after the completion of therapy. Throughout the study period, no concomitant therapy will be permitted.
Exclusion Criteria:
All enrolled participants receive Mundij wa Mushil-i Sawdā orally once daily for 40 days. For topical treatment, each participant applies Marham-e-Asfedaj (Drug A) to psoriatic plaques on one side of the body and Coal Tar with Salicylic Acid 3% solution (Drug B) to matching plaques on the contralateral side, for 60 days. Side allocation (right vs. left) is randomized for each participant.
Drug: Marham Asfedaj · Drug: Mundij wa Mushil Sawda (Unani Oral decoction) · Drug: Coal tar 1% & Salicylic acid 3 % solution
Marham Asfedaj (Unani ointment) applied locally twice daily for 60 days
Also known as: Unani Ointment
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 topical application twice daily for 60 days
Psoriasis Area Severity Index
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.
Time frame: 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)
Reversal/ Changes in Histopathology
Histopathological changes in the treatment site will be evaluated
Time frame: skin biopsy for assessing Histopathological changes will be taken on baseline (Day 0) and after treatment (day 60)
Simplified Psoriasis Index (SPI)
The Simplified Psoriasis Index (SPI) is a validated, comprehensive tool designed to assess psoriasis severity, psychosocial impact, and treatment history in both clinical and research settings. It was developed to provide a user-friendly alternative to PASI, offering greater sensitivity to functionally important and psychosocially sensitive sites. The SPI consists of three domains: 1. Current Severity Score (SPI-s): Evaluates psoriasis across ten body sites (e.g., scalp, hands, face, genitals), each scored from 0 (clear) to 5 (very severe), allowing a maximum score of 50. 2. Psychosocial Impact Score (SPI-p): A patient-rated score (0-10) indicating how much psoriasis affects daily life and well- being. 3. Past History and Intervention Score (SPI-i): Captures treatment burden (0-10), reflecting the intensity and number of prior interventions (e.g., phototherapy, systemic, biologic treatments).
Time frame: SPI will be assessed every 2 weeks I,e. Day 0 (baseline), day 15, day 30, day 45, day 60 and post treatment (day 90)
Dermatological Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a widely used, validated questionnaire developed to measure the impact of skin diseases on patients' quality of life. It is especially relevant in chronic dermatological conditions such as psoriasis, eczema, and acne. The DLQI consists of 10 questions, each scored from 0 (not at all) to 3 (very much), covering the following domains: Symptoms and feelings, Daily activities, Leisure, Work and school, Personal relationships, Treatment difficulties. The total score ranges from 0 to 30, with higher scores indicating greater impairment.
Time frame: DLQI will be assessed every 2 weeks from baseline (day 0), Day 15, day 30, day 45, day 60 and post treatment follow up (Day 90
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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