Evaluation of the outcome of modified conventional Ksharasutra therapy(MC-KST) for the management of Bhagandar(fistula-in-ano)- A prospective study.
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Healing of Bhagandara (fistula in Ano) w.r.t. Faster Recovery(in Days) ,Pain, Recurrence(FRPR).
概览
简要总结
This is a prospective study to appraise the efficacy of a modified surgical technique that is Modified conventional Ksharsutra therapy (MC-KST) technique w.r.t FRPR (Faster recovery, Pain, Recurrence) for the management of Bhagandar/Fistula in ano In 30 patients of age 20 to 60 years considering the riju bhagandar/trans-sphincteric Fistula and Controlled HTN & DM. Study will be conducted at AIIA with duration of 6 week of treatment with follow up at every month for 6 months,the Primary outcome will be Healing of the fistulous tract, pain and recurrence. The standard treatment will be given in the study duration.
Hypothesis-MC-KST is an effective surgical technique for the management of Bhagandara (Fistula- in-Ano) w.r.t. Faster Recovery, Pain, Recurrence (FRPR).
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Trans-sphincteric Fistula in Ano / Riju Bhagandara Controlled HTN & DM.
排除标准
- •1.Unfit for surgery 2.Fistula in ano secondary to other diseases 3.Tuberculosis, Uncontrolled HTN and DM.
- •4.Crohn’s/ Ulcerative colitis 5.CA Rectum and CA Colon.
- •6.VDRL, HIV and HBsAg positive patients.
- •7.Osteomyelitis (Pelvic bones and coccyx) 8.Bleeding disorders OTHER CONDITIONS 9.Pregnancy.
- •10.High anal fistula 11.Patient who are not willing to be part of study.
结局指标
主要结局
Healing of Bhagandara (fistula in Ano) w.r.t. Faster Recovery(in Days) ,Pain, Recurrence(FRPR).
时间窗: treament for 6 weeks followed by follow-up at every month for 6 months
次要结局
未报告次要终点
研究者
Dr Himanshu Rathore
All India Institute of Ayurveda,Gautampuri, Sarita Vihar New Delhi