An Open Label Double Arm Clinical Study to Compare the Effect of Gomutra Siddha Apamarga Pratisaraniya Ksharakarma and Udaka Siddha Apamarga Pratisaraniya Ksharakarma in Abhyantara Arshas.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- shrinkage of haemorroidal mass
研究概览
简要总结
This is an open label double arm clinical study to compare the effect of Gomutra Siddha Apamarga Pratisaraniya ksharakarma and Udaka Siddha Apamarga Pratisaraniya Ksharakarma in Arshas.
Group A Comprising of 20 patients of internal haemorrhoids will be subjected to Gomutra Siddha Apamarga Pratisaraniya ksharakarma
Group B Comprising of 20 patients of internal haemorrhoids will be subjected to Udaka Siddha Apamarga Pratisaraniya Ksharakarma
Patients of both group will be observed for 21 days of followup period.
primary outcome will be shrinkage of haemorrhoidal mass and secondary outcomes will be cessation of bleeding per anum , cessation of mucoid discharge per anum , relief of pruritis ani .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 69.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient above 18 and below 70 years of age.
- •Patients with clinical features of 1st and 2nd degree haemorrhoids.
排除标准
- •Associated with any other anorectal diseases Pregnancy and Lactating women Fecal incontinence Known case of HBV, HCV & HIV infection Uncontrolled Diabetes mellitus 1 and 2 Contraindicated for kshara karma as per Ayurveda.
结局指标
主要结局
shrinkage of haemorroidal mass
时间窗: 21 days
次要结局
- cessation of bleeding per anum(cessation of mucoid discharge per anum)
