A comparative open label study to evaluate the effficacy of Siddha prebiotic Panchadeepakini chooranam in management of Psoriasis(Kalanjagappadai)among patients attending special OPD at Government Siddha Medical College Hospital-A pilot study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The rate of acheivement of PASI 50 or PASI 75 will be compared in both the study groups
研究概览
简要总结
Psoriasis is a disease of T cells with interplay of genetic factors and environmental influences such as infections and drugs. Gut dysbiosis is associated with altered immune response promoting thedevelopment of skin diseases like psoriasis, atopic dermatitis, acne vulgaris, dandruff and skincancer.These days probiotics and prebiotics are used as novel therapeutic approaches for psoriasis. Spices displayed prebiotic like activity by promoting the beneficial bacteria and suppressing growth of pathogenic bacteria suggesting their potential role in regulation of intestinal microbiota and enhancement of gastrointestinal health. Qing et al states that spices extracts enhanced the growth of Bifidobacterium spp and Lactobacillus spp. All spices exhibited inhibitory activity against selected Ruminococcus spp. Siddha medicines possess spices as their most essential components. Panchadeepakini chooranam is made of five spices namely Zingiber officinale, Piper nigrum, Piper longum, Elletaria cardomom, Cuminum cyminum. According to
researches, the spices present in panchadeepakini chooranam increases the abundance of gut microbe Bifidobacterium, reduces inflammation of intestinal epithelium due to gut microbial dysbiosis. Since development of Psoriasis is associated with gut dysbiosis,it is considered to evaluate the efficacy of Panchadeepakini chooranam in Psoriasis patients attending special OPDas an add on treatment in accelerating the achievement of PASI 50 or PASI 75.
A supportive invitro study was asked to completed before starting the clinical trial. I have completed the preclinical invitro study and now registering for ctri number to proceed with clinical study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Day(s) 至 60.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients with moderate and severe psoriasis characterized by PASI score greater than or equal to 5.
排除标准
- •Known case of Diabetes Mellitus Pregnant and lactating mothers.
结局指标
主要结局
The rate of acheivement of PASI 50 or PASI 75 will be compared in both the study groups
时间窗: 3 months
次要结局
- To estimate the reduction of investigatory parameters(3 months)
研究者
Dr Atchaya Selvaraju
Government Siddha Medical College ,Chennai