A randomized controlled trial to determine the safety and efficacy of Sivanarvembu Kuzhithailam (SVK) in the management of Kalanjagapadai (Psoriasis).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- No significant variation in the haematological, biochemical parameters.
研究概览
简要总结
A randomized controlled trial to determine the safety and efficacy of Sivanarvembu Kuzhithailam (SVK) in the management of Kalanjagapadai (Psoriasis)
This study has been planned to assess the safety and efficacy of the trial drugs in the management of Kalanjagapadai (Psoriasis). It is a triple arm trial with 30 participants in each group. The trial drugs will be administered for a period of 3 months with 6 months follow up period. The first arm will be receiving Sivanarvembu Kuzhithailam with Sivanarvembu chooranam internally, second group will be receiving Vetpalai thailam externally and the third group will be receiving Sivanarvembu Kuzhithailam internally and Vetpalai thailam externally. The study has been approved by the IHEC of SRRI, Puducherry. Study participants are recruited from March 2023. Now recruitment is in progress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Well defined nonindurated dry erythematous lesions with scaling A minimum PASI score of 12.0 at screening Psoriasis covering ≥ 10% of total BSA Dermatology life quality index (DLQI) score at least 4 Duration of disease at least 6 months Plaque psoriasis clinically stable for at least 3 months prior to screening Body weight ≤ 100 kg.
排除标准
- •Guttate, erythrodermic, or pustular psoriasis Clinically significant psoriasis flare during screening or at the time of enrolment History of any secondary skin infection Pregnancy or lactation Patients undergoing treatment for chronic illness Diabetes mellitus, Cardiovascular diseases, Tuberculosis, Hypertension etc Patient with a history of alcohol or drug abuse Candidate who had been previously treated (e.g., cyclosporine, corticosteroids, methotrexate).
结局指标
主要结局
No significant variation in the haematological, biochemical parameters.
时间窗: 0th day to 46th and 91st day
PASI Score: Response status at the end will be determined as follows:
时间窗: 0th day to 46th and 91st day
Responder: Any subject whose PASI score decreased ≥ 50% from day 0 to day 46 and day 91.
时间窗: 0th day to 46th and 91st day
Partial responder: Any subject whose PASI score decreased ≥ 30% but 50% from day 0 to day 46 and day 91.
时间窗: 0th day to 46th and 91st day
Non-responder: Any subject whose PASI score decreased 30% from day 0 to day 46 and 91st day.
时间窗: 0th day to 46th and 91st day
次要结局
- Dermatology Life Quality Index: Any subjects whose DLQI score increase 4 points and above.(Mode of action can be simulated)