A comparative clinical study on the Effectiveness of Nishadi sutra against Apamarga ksharasutra in Bhagandara.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1.Unit cutting time- assessed by weekly measurement of sutra length
研究概览
简要总结
In this study Nishadi sutra mentioned in Basavarajeeyam is compared with
Apamarga ksharasuthra, the standard one, in its cutting effect along with pain and burning sensation. 46 participants,selected from the OPD and IPD of Salyatantra, Government Ayurveda College Hospital, Tripunithura satisfying the inclusion and exclusion criteria will be allocated to both trial and control group .Nishadi sutra is applied in the study group and Apamarga ksharasutra in the control group. Assessment of cutting effect is done by calculating Unit cutting time(UCT) . Length of thread is measured on every 7 th day during thread change. Assessment of pain, burning sensation will be based on the Visual Analogue Scale and grading by Paul O Madson and Peter respectively and both are assessed from the first day of application and on every 7th day of thread change. The observations thus obtained will be analysed using a suitable statistical method.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Low anal fistula diagnosed by clinical examination Participants with age group of 18-60 years Participants with informed written consent.
排除标准
- •Fistula associated with Ulcerative Colitis, Crohn’s disease, Colorectal carcinoma, Tuberculosis.
- •Fistula in participants with HIV, Hepatitis B or Veneral diseases.
结局指标
主要结局
1.Unit cutting time- assessed by weekly measurement of sutra length
时间窗: assessed properly on its change on 7th day. Later on, all outcome variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days.
2. Reduction in pain(VAS scale)
时间窗: assessed properly on its change on 7th day. Later on, all outcome variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days.
3.Reduction in burning sensation assessed through grading.
时间窗: assessed properly on its change on 7th day. Later on, all outcome variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days.
次要结局
- Reduction in pain(VAS scale)(Reduction in burning sensation assessed through grading.)
研究者
Vaisali K S
Government Ayurveda College,Trippunithura.