Efficacy of Arka Ksheera–based Tankana Ksharasutra against Apamarga Ksharasutra along with standard treatment in Low Anal Fistula: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Unit Cutting Time of the Ksharasutra measured by the formaula Total number of days for cut through /Initial length of Ksharasutra
研究概览
简要总结
Present study is a Randomised controlled trial which has been undertaken to evaluate efficacy of Arka Ksheera based Tankana Ksharasutra in the management of Low Anal Fistula and to compare its efficacy with Apamarga Ksharasutra along with standard treatment .50 Participants clinically diagnosed with Low Anal Fistula will be selected from OPD and IPD of Shalyatantra department, of Government Ayurveda College hospital Thiruvananthapuram satisfying both inclusion and exclusion criteria. Block Randomisation with allocation concealment using sequentially numbered opaque sealed envelopes will be done with the help of a faculty / statistician who is not directly involved in the study. Participants will be blinded. Trial group will receive Arkaksheera based Tankana Ksharasutra while the control group will receive Apamarga Kshara sutra. Changing of Ksharasutra will be done on every 7th day upto eight weeks or till complete cutting through the tract .Assessment will be conducted based on both objective and subjective parameters including UCT, pain and discharge, on every 7 th day. Collected data will be statistically analyzed and the study will be concluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of Low Anal Fistula.
排除标准
- •Known cases of colorectal carcinoma, Crohns disease, ulcerative colitis, and tuberculosis.
- •Known cases of uncontrolled diabetes mellitus, uncontrolled hypertension, HIV, hepatitis B, and venereal diseases.
结局指标
主要结局
Unit Cutting Time of the Ksharasutra measured by the formaula Total number of days for cut through /Initial length of Ksharasutra
时间窗: Assessment of Unit Cutting Time will be done on 0th day (after Ksharasutra application),7thday(first week),2nd week,3rd week, 4th week, 5th week, 6th week, 7th week, 8th week or till complete cut through of tract
次要结局
- Efficacy of Ksharasutra in pain assessed by the VAS scale & discharge assessed by the Paul O Madson & Peter grading.(Assessment will be done on 0th day & every seventh day after Ksharasutra application till eight weeks or up to complete cut-through of the tract.)
研究者
Dr Remya VR
Government Ayurveda College Thiruvananthapuram