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Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis

19. September 2026 aktualisiert von: Shavana Fathima, National Institute of Unani Medicine, Bengaluru

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?

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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

54

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Indien
    • Karnataka
      • Bangalore, Karnataka, Indien, 560091
        • National Institute of Unani Medicine
        • Kontakt:
        • Hauptermittler:
          • Shavana Fathima, BUMS, MD, (PhD)

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Marham-e-Asfedaj + Salicylic Acid Comparison (Split-Body)

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.
Arzneimittel: Marham Asfedaj

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

Andere Namen:
  • Unani Ointment
Arzneimittel: 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

Arzneimittel: Coal tar 1% & Salicylic acid 3 % solution

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Psoriasis Area Severity Index
Zeitfenster: 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.
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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reversal/ Changes in Histopathology
Zeitfenster: 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
skin biopsy for assessing Histopathological changes will be taken on baseline (Day 0) and after treatment (day 60)
Simplified Psoriasis Index (SPI)
Zeitfenster: 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:

  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).
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)
Zeitfenster: 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.
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Institute of Unani Medicine, Bengaluru

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. April 2027

Primärer Abschluss (Geschätzt)

1. April 2029

Studienabschluss (Geschätzt)

1. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

19. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. September 2026

Zuerst gepostet (Tatsächlich)

25. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NIUM/IEC/2025-26/047PhD/Moal/2

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

IPD-Sharing-Zeitrahmen

once trial completed and published or under publication , the IPD shall be available for peer review

IPD-Sharing-Zugriffskriterien

reviewers or journal editors demanding to see the data to support that trial publication

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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