A comparative clinical study to evaluate the efficacy of Tankana ksharasutra and Nimba ksharasutra in the management of Bhagandara Vis-a-vis Fistula in ano
试验速览
- 阶段
- 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
- Unit cutting time (UCT)8 days/cm
研究概览
简要总结
This study is a randomized, open label, parallel group,active controlled trial comparing the efficacy
of Tankana Ksharasutra (type of medicated Seton with processed borex) and Nimba Ksharasutra
(Medicated Seton with processed azadiracta indica) tied in uncomplicated fistula tract, and
changing these Ksharasutra after 7th day till the complete cutting and healing of the tract
meanwhile assessing the pain, pus discharge, itching per anum every 7th day. Cutting and healing
of the tract will be assessed by Unit cutting time (UCT) i.e time taken in days to cut 1 cm of the
fistula tract. Patients with uncontrolled Dm, HTN, TB and multiple fistulas tract are excluded.
Primary outcome of the proposal is to have UCT less than 8 days/cm. Which will be calculated by
based on overall duration of treatment within 1 yea
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject with signs and symptoms of Bhagandara 2.Subject with low anal fistula.
- •3.Subject of fistula in ano with systemic diseases like Diabetes mellitus and Hypertension which are under control.
- •4.Subject fit for Ksharasutra.
排除标准
- •1.Subject having high anal fistula and multiple tracts.
- •2.Subject with acute or chronic ulcerative colitis, crohn’s disease, Fistula secondary to tuberculosis.
- •3.Subject associated with uncontrolled Hypertension/Diabetes mellitus, Anaemia, Cardiac disorders, and Malignancy.
- •5.Pregnant women.
结局指标
主要结局
Unit cutting time (UCT)8 days/cm
时间窗: At baseline, 1st week,2nd week,3rd week, 4th week,5th week till complete cutting of the fistula tract within 1 year
次要结局
- Objective & Subjective criteria Reduction in pain, pus discharge, itching, unit cutting time less than 2(Less than 2)
研究者
Dr Hapani Uttamkumar Vitthalbhai
Ayurveda Mahavidyalaya and Hospital Hubbali