CTRI/2020/08/027446尚未招募2 期
Phase II Non randomised open clinical evaluation of siddha medicine kattu karunai chooranam for mulai moolam ( Haemorrhoids)
Government Siddha Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月31日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome is mainly assessed byreduction in clinical symptoms measured by reduction in pain, cessation of bleeding during defecation constipation
研究概览
简要总结
This is Phase II Non randomised open clinical evaluation trial to study the safety and efficacy of siddha Medicine Kattu Karunai Chooranam for Mulai Moolam. The trial Drug is given 1 gram twice a day with cows butter milk for 48 days. Clinical trial conducted after condicting after preclinical toxicity study. The trial drug Kattu Karunai Chooranam mentioned in Agathiyar 2000 part 2. During the trial all the study related data will be recorded and documented. Ater complition of the 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
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with appropriate symptoms like Bleeding during defecation Constipation Pain in anal region Per rectal examination pile mass present.
排除标准
- •Pregnant and lactating mothers Second degree haemorrhoids External haemorrhoids Fissure in ano Fistula Ca Rectum Rectal Prolapse Hb less than 8mg/dl.
结局指标
主要结局
Outcome is mainly assessed byreduction in clinical symptoms measured by reduction in pain, cessation of bleeding during defecation constipation
时间窗: 48 days
次要结局
- Secondary outcome is comparing the safety parameters before and after treatment(48 days)
研究者
研究点 (1)
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