Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Shavana Fathima, BUMS, MD, (PhD)
- 電話番号：+918861102643
- メール：dr.shavanafathima@gmail.com
研究場所
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Karnataka
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Bangalore、Karnataka、インド、560091
- National Institute of Unani Medicine
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コンタクト：
- Shavana Fathima, BUMS, MD, (PhD)
- 電話番号：+918861102643
- メール：dr.shavanafathima@gmail.com
-
主任研究者：
- Shavana Fathima, BUMS, MD, (PhD)
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
Marham Asfedaj (Unani ointment) applied locally twice daily for 60 days
他の名前：
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 topical application twice daily for 60 days |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Psoriasis Area Severity Index
時間枠：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:
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reversal/ Changes in Histopathology
時間枠：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)
時間枠：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:
|
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)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NIUM/IEC/2025-26/047PhD/Moal/2
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有時間枠
once trial completed and published or under publication , the IPD shall be available for peer review
IPD 共有アクセス基準
reviewers or journal editors demanding to see the data to support that trial publication
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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