Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis

NCT07841314 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NIUM/IEC/2025-26/047PhD/Moal/2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Plaque Psoriasis; Plaque Psoriasis; Psoriasis; Taqashshur al Jild

Keywords

Plaque psoriasis; Taqashshur al Jild; Histology; Dermatology; Marham Asfedaj; Mundiz wa mushil Sawda; purgative therapy; Unani medicine; Unani Formulation; Unani formulation in Plaque psoriasis; Marham Asfedaj in plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Secondary Outcomes (3)

• Reversal/ Changes in Histopathology

  skin biopsy for assessing Histopathological changes will be taken on baseline (Day 0) and after treatment (day 60)

• Simplified Psoriasis Index (SPI)

  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)

  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

Study Arms (1)

Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body)

EXPERIMENTAL

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

Interventions

Marham Asfedaj DRUG

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

Also known as: Unani Ointment

Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body)

Mundij wa Mushil Sawda (Unani Oral decoction) DRUG

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

Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body)

Coal tar 1% & Salicylic acid 3 % solution DRUG

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

Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subjects with Symmetrical Plaque Psoriasis lesions
• Willing to consent for all trial requirements

You may not qualify if:

• Subjects with severe Plaque Psoriasis PASI \>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

Sponsors & Collaborators

• National Institute of Unani Medicine, Bengaluru: lead

Study Sites (1)

National Institute of Unani Medicine

Bangalore, Karnataka, 560091, India

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Coal Tar; Salicylic Acid; Solutions

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures; Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Pharmaceutical Preparations

Central Study Contacts

Shavana Fathima, BUMS, MD, (PhD)

CONTACT

+918861102643; dr.shavanafathima@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A Randomised open labelled split-body comparative Clinical Trial

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: once trial completed and published or under publication , the IPD shall be available for peer review
• Access Criteria: reviewers or journal editors demanding to see the data to support that trial publication

Locations

IN (1)