Comparative clinical evaluation of Apamarga kshar sutra and Gunja kshar sutra ligation in Bhagandara
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subjective Parameters–
研究概览
简要总结
In this trial we are selecting patients of Bhagandara and dividing them into two groups with 30 patients in each group. In 1st group, we will do intervention with standard Apamarga kshar sutra ligation of fistula tract and in 2nd group, we will do intervention with Gunja kshar sutra ligation of fistula tract. Comparative study to be done on the basis of assessment based on subjective and objective parameters. Subjective parameters includes Burning sensation , Itching, Discharge, Pain and Inflammation and Objective parameters includes unit cutting time
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical signs and symptoms of all types of Bhagandara 2) Patient age group ranging between 18-60 years of either sex 3) Patients who are willing for the trial 4) Newly diagnosed as well as pre-diagnosed cases of Bhagandara.
排除标准
- •HBsAg, HCV and HIV positive patients. Patient below 18 and above 60 years of age of either sex. Pregnancy Secondary fistulas due to:.
- •Crohn’s disease 2) Ulcerative colitis 3) Carcinoma of Rectum 4) Pelvic Abcess 5) Tuberculosis 6) Osteomyelitis of Pelvic Bone. 7) Patient having uncontrolled Diabetes and Hypertension. 8) Other systemic disorder.
结局指标
主要结局
Subjective Parameters–
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
Itching
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
Burning sensation
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
Discharge
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
Pain
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
Inflammation
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
Objective parameters-
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
unit cutting time
时间窗: Assessment will be done at baseline, followed by | weekly assessment until the fistula tract is | completely healed
次要结局
- Subjective Parameters–(Itching)
研究者
Raghav Sharma
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan