Single arm clinical study of Yavakshara Ksharasutra in management of Bhagandara vis-a-vis fistula in ano.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in length of tract
研究概览
简要总结
The study will be initiated after getting clearance from Institutional Ethics Committee.
The research study will be registered in Clinical Trial Registry of India.
This study is single arm clinical study.
Patient will be selected as per inclusion/exclusion criteria.
There will be all patients having characteristics according to inclusion criteria.
Once the patient is enrolled tests will be done accordingly and after explaining procedure and taking written informed consent procedure will be done.
Follow up will be taken on every 7th day during the treatment.
Discontinue criteria If subject rejects treatment if any adverse drug reaction/patient did not come for follow up or any aggravated symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed as case of Bhagandara(fistula in ano specially low level fistula).
排除标准
- •Patients suffering from Bhangandara(Fistula in ano), associated with uncontrolled DM, Hypertension, HIV, HbsAg and history of tuberculosis.
- •Patients with multiple fistula, haemorrhoids, Pregnancy will be excluded from study.
结局指标
主要结局
Reduction in length of tract
时间窗: 7th, 14th and 21st day
次要结局
- complete healing of fistular tract(7th, 14th and 21st day)
研究者
Dr Netraj Suryawanshi
Bharati Vidyapeeth (Deemed to be University)