A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Safuf-i-musaffi khas and Ravghan-i-Hina in the Management of Taqashshur al-Jild(Psoriasis)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical assessment will be done at baseline visit and at each follow-up visit 2nd, 4th and 8th weeks and the assessment of response to treatment will be made on the basis of the change in PASI Score after 8th weeks of therapy. For the efficacy of the test drug, 25% change in appearance and symptomatic relief will be considered significant.
研究概览
简要总结
Psoriasis is a chronic inflammatory skin disease affecting 0.44-2.8% of the Indian population, often manifesting in the third or fourth decade of life. Conventional treatments, such as corticosteroids and phototherapy, pose risks including hepatotoxicity, phototoxicity, and relapse. Unani medicine, with holistic approaches, offers safer alternatives. This randomized, parallel-group, open-label, active-controlled clinical study aims to evaluate the safety and efficacy of Safuf-i-Musaffi Khas and Ravghan-i-Hina in treating Taqashshur al-Jild (Psoriasis). Eligible participants will be randomized to either the test or control groups. Baseline and post-treatment laboratory investigations will be conducted. The study duration is 8 weeks, with an estimated total sample size of 60 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The participants will be included in the study on the basis of the following criteria:
- •Participants of any sex aged between 18 to 60 years.
- •Patients clinically diagnosed with Taqashshur al-Jild (Psoriasis).
- •Patients with a Psoriasis Area and Severity Index (PASI) score equal to or more than 10%.
- •Patients with a minimum psoriasis duration of at least six months.
- •Patients who have failed or are intolerant to at least one conventional systemic therapy for psoriasis.
- •Patients with a Dermatology Life Quality Index (DLQI) score more than
- •Participants willing to provide written informed consent and comply with study procedures.
排除标准
- •The following patients will be excluded:
- •Participants aged below 18 years or above 60 years.
- •Known cases of significant pulmonary, cardiovascular, hepatic, renal dysfunction, malignancy, HIV/AIDS, or other systemic diseases.
- •Pregnant or lactating women.
- •Patients unwilling to attend the clinical trial.
- •Patients with other skin conditions, such as eczema or chronic dermatitis, that could interfere with psoriasis assessment.
- •Patients currently taking medications that interfere with study drug metabolism or psoriasis severity.
- •Patients with a history of alcohol or drug abuse.
- •Patients with known hypersensitivity to any component of the study medications.
结局指标
主要结局
Clinical assessment will be done at baseline visit and at each follow-up visit 2nd, 4th and 8th weeks and the assessment of response to treatment will be made on the basis of the change in PASI Score after 8th weeks of therapy. For the efficacy of the test drug, 25% change in appearance and symptomatic relief will be considered significant.
时间窗: 8 weeks
次要结局
- Improvement in IGA from baseline(8 weeks)
- Improvement in DLQI from baseline(8 weeks)
- Photographic Assessment: Digital photography of all lesions will be done using conditions (fixed room, fixed lighting & fixed camera settings) at baseline & 8th week.(8 weeks)