Chronic Plaque PsoriasisPhase 2NCT07841314
Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis
A Phase 2 study testing Marham Asfedaj, Mundij wa Mushil Sawda (Unani Oral decoction) and Coal tar 1% & Salicylic acid 3 % solution in people with Chronic Plaque Psoriasis and Plaque Psoriasis, run by National Institute of Unani Medicine, Bengaluru at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Plaque Psoriasis, Plaque Psoriasis, Psoriasis
- What is being tested?
- Marham Asfedaj, Mundij wa Mushil Sawda (Unani Oral decoction) and Coal tar 1% & Salicylic acid 3 % solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2027to 1 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
National Institute of Unani Medicine
Bangalore, Karnataka, 560091
Shavana Fathima, BUMS, MD, (PhD), +918861102643, dr.shavanafathima@gmail.com
Shavana Fathima, BUMS, MD, (PhD)
About this study
Official 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
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?
Read more
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
Read the detailed description
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.
- Being tested
- Marham Asfedaj, Mundij wa Mushil Sawda (Unani Oral decoction), Coal tar 1% & Salicylic acid 3 % solution
- 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
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marham AsfedajDrug
Also called Unani Ointment
Marham Asfedaj (Unani ointment) applied locally twice daily for 60 days
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 % solutionDrug
Coal tar 1% \& Salicylic acid 3% Solution topical application twice daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Marham Asfedaj; Drug: Mundij wa Mushil Sawda (Unani Oral decoction); Drug: Coal tar 1% & Salicylic acid 3 % solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Histopathological changes in the treatment site will be evaluated
Measured: 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:
- 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).
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Apr 2027 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Randomised open labelled split-body comparative Clinical Trial
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Unani Medicine, Bengaluru
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shavana Fathima, National Institute of Unani Medicine, Bengaluru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841314
- Sponsor's protocol ID
- NIUM/IEC/2025-26/047PhD/Moal/2
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07841314
- Acronym / sponsor ID
- NIUM/IEC/2025-26/047PhD/Moal/2
- Keywords
- Plaque psoriasis, Taqashshur al Jild, Histology, Dermatology, Marham Asfedaj, Mundiz wa mushil Sawda, purgative therapy, Unani medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Institute of Unani Medicine, BengaluruUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Randomised open labelled split-body comparative Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body) | Experimental | Drug: Marham Asfedaj, Drug: Mundij wa Mushil Sawda (Unani Oral decoction), Drug: Coal tar 1% & Salicylic acid 3 % solutionAll 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marham AsfedajAlso: Unani OintmentMarham Asfedaj (Unani ointment) applied locally twice daily for 60 days | Drug | Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body) |
| 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 | Drug | Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body) |
| Coal tar 1% & Salicylic acid 3 % solutionCoal tar 1% \& Salicylic acid 3% Solution topical application twice daily for 60 days | Drug | Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body) |
Primary outcome
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.
3 secondary outcomes
Reversal/ Changes in Histopathology
Time frame: skin biopsy for assessing Histopathological changes will be taken on baseline (Day 0) and after treatment (day 60)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Marham Asfedaj, Mundij wa Mushil Sawda (Unani Oral decoction) and Coal tar 1% & Salicylic acid 3 % solution in people with Chronic Plaque Psoriasis and Plaque Psoriasis, run by National Institute of Unani Medicine, Bengaluru at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shavana Fathima, BUMS, MD, (PhD) (+918861102643, dr.shavanafathima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.