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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Psoriasis Area Severity Index
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Marham Asfedaj (Drug)
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.
干预措施: Mundij wa Mushil Sawda (Unani Oral decoction) (Drug)
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.
干预措施: Coal tar 1% & Salicylic acid 3 % solution (Drug)
结局指标
主要结局
Psoriasis Area Severity Index
时间窗: 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.
次要结局
- Reversal/ Changes in Histopathology(skin biopsy for assessing Histopathological changes will be taken on baseline (Day 0) and after treatment (day 60))
- Simplified Psoriasis Index (SPI)(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)(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)
研究者
Shavana Fathima
Doctor
National Institute of Unani Medicine, Bengaluru