Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-60
SponsorNational Institute of Unani Medicine, Bengaluru
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Marham Asfedaj
DrugMarham Asfedaj (Unani ointment) applied locally twice daily for 60 days
Mundij wa Mushil Sawda (Unani Oral decoction)
DrugMundij 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
DrugCoal tar 1% \& Salicylic acid 3% Solution topical application twice daily for 60 days
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body)Experimental treatment 3 interventions
Trial outcomes
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.
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)Secondary outcomes
1
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)2
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)3
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 90Sponsors and contacts
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Source ClinicalTrials.gov
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