A randomised controlled clinical study of Aragvadhadi Ksharsutra and Apamarga Ksharsutra in the management of Bhagandara.
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
- Reduction in length of tract.
研究概览
简要总结
The study will be conducted after obtaining permission from the Institutional Ethics Committee and will be registered in CTRI, India. • As per Inclusion / Exclusion criteria patient will be selected. • Whole research procedure and aim will be clearly informed to patients and consent form will be signed and CRF will be filled. • Conduct of procedure: Patient will be examined in OPD on the day of first visit with necessary Investigations. After Investigations and deemed fit the patient will be counselled for enrollment in the study. • Procedure will be explained to the patient that ksharsutra will be applied and tied to the fistula, and is kept for one week, the kshar sutra will be changed weekly. any unexpected risk occur during the trial as an outcome of research purpose. All the possible care will be taken by hospital till patient is normalized. • Some subjects might experience symptoms like pain, burning Sensation,Itching etc, in such a case, cause will be found out and proper treatment will be advised. • Patient will be observed and if patient is not following the treatment protocol or not willing to continue treatment can be considered as a drop out.
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
- 15.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient having low level fistula.
排除标准
- •Patients having bleeding disorders patient on anti coagulation drugs and ca rectum Pregnant women Chronic or acute ulcerative collitis Intestinal and pelvic malignancies Veneral diseases and HIV Multiple fistulae originating mainly due to tuberculosis Crohn’s disease Uncontrolled DM.
结局指标
主要结局
Reduction in length of tract.
时间窗: Centimeter per 1 week
次要结局
- Complete healing of fistula tract(4 to 5 weeks)
研究者
Dr Akanksha Dasila
Bharti vidyapeeth deemed to be university, college of ayurved, pune
