A comparative clinical effect of Chedankarma followed by Ksharkarma and Ksharsutra threading in the management of low anal fistula
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Healing of fistulous tract
研究概览
简要总结
Ksharsutra application in fistula in ano takes upper hand in the various surgical modalities available for the treatment of this ano-rectal condition but it is associated with excrutiating pain while changing the ksharsutra and sometimes due to long duration of treatment patient’s compliance is less and many dropouts during treatment.This study proposes management of fistula in ano by laying open the tract (Chedankarma) followed by cauterization (kshar karma This is a clinical study to compare the efficacy of Chedakarma followed by ksharkarma and ksharsutra , wherein 69 patients diagnosed with Low anal Fistula in ano wias be selected from the surgery OPD , Shalyatantra Department at JSAM, Nadiad and randomly divided into two group . In Group A(n=36) -Fistulotomy with Kshar application and in Group B(n=33)= ksharsutra application was done. Pain in post-operative period , discharge and wound size was be assesed
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of linear low anal
- •Intersphincteric and Transphincteric fistula-in-ano will be included.
- •Patients having signs and symptoms of Bhagandara like Pidika, Vedana, Srava and Kandu in Gudapradesha will be included.
- •Patients medically fit for surgery will be included.
排除标准
- •Patients with age below 18 years and above 70 years
- •High anal fistula
- •Complex fistula in ano with multiple tracts and abscess (MRI Grade, II, IV to V)
- •Horseshoe fistula
- •Crohn’s disease
- •Ulcerative colitis
- •Uncontrolled Diabetes Melitus
- •Uncontrolled Hypertension
- •Cardiovascular disease i.e., Ischemic heart disease, Myocardial Infarction, CCF etc
- •Pregnant and lactating female
- •Malignancy of anorectum or other organs
- •Rectal prolapse
- •Hepatitis B, Tuberculoses, HIV & VDRL positive cases.
结局指标
主要结局
1. Healing of fistulous tract
时间窗: 1 month
2. The assessment of the relief signs and symptoms will be done based on a gradation scoring pattern and as per specially prepared research Performa The suitable statistical tests paired and unpaired student t-tests will be applied
时间窗: 1 month
次要结局
- improved quaily of life patients(1 months)
研究者
Dr Hetal Nakrani
J S Ayurveda Mahavidhyalaya Nadiad