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NCT Number: NCT07841314

Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis

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

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Key information

Conditions

Chronic Plaque Psoriasis Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Taqashshur al Jild

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Unani Medicine

Bangalore, Karnataka, 560091, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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

Treatment and study plan

Marham Asfedaj

Drug

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

Other names: Unani Ointment

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

Coal tar 1% & Salicylic acid 3 % solution

Drug

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

Primary outcomes

  1. Psoriasis Area Severity Index

    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)

    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.

Secondary outcomes

  1. Reversal/ Changes in Histopathology

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

    Histopathological changes in the treatment site will be evaluated

  2. Simplified Psoriasis Index (SPI)

    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)

    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:

    • 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.
    • Psychosocial Impact Score (SPI-p): A patient-rated score (0-10) indicating how much psoriasis affects daily life and well- being.
    • 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).

  3. Dermatological Life Quality Index (DLQI)

    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

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

National Institute of Unani Medicine, Bengaluru

Other

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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