CTRI/2017/04/008435招募中2 期
A clinical study on kalladaippu (Urolithiasis) with the evaluation of siddha drug " Karpoora silasathu parpam "
Dr S Sarathkumar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年3月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mainly assessed by reduction of clinical symptoms and comparing before and after treatment
研究概览
简要总结
This is a single arm open clinical trial to study the safety and efficacy of Siddha trial drug Karpoora Kilasathu parpam. The trial drug is given 100 milli grams twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Karpoora silasathu parpam is mentioned in Agasthiyar chendhooram 300. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •1.History of Urolithiasis (with USG-Whole Abdomen reports) 2.Pain the Flank 3.Burning Micturition 4.Nausea 5.Vomiting 6.Oliguria 7.Dysuria 8.Haematuria 9.Fever 10.Stone size-4 to 10mm.
排除标准
- •1.Hydro nephrosis 2.Stag horn calculus 3.Calculi associated with elevated serum creatinine level 4.Calculi in pregnancy.
结局指标
主要结局
Mainly assessed by reduction of clinical symptoms and comparing before and after treatment
时间窗: 48 days
次要结局
- Any toxicity of the drug(14 days)
研究者
研究点 (1)
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