A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Kushthadi Ointment In The Management Of Post Operative Fistulectomy Wound As Compared With Povidone Iodine 10 percent Ointment
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- - Assessment of Relief in symptoms of Bhagandara such as Shool, Strava, Shotha, Sparshasahatva and gandha
研究概览
简要总结
Two arm, Open labeled, randomized comparative clinical study
Study setting- Clinical study Selection of patients-
Selection of Patients from the IPD and OPD of the concern Institute fulfilling POST OPERATIVE FISTULECTOMY WOUND will be done as per inclusion and assessment criteria from OPD will be enrolled in this study.
There will be 70 number of patients either gender from ShalyaTantra OPD/IPD of concerned institute, divided into 2 groups
Groping of patients-
-
Study group : 35 Patients.
-
Control group : 35 Patients.
Study population-
Patients of POST OPERATIVE FISTULECTOMY WOUND fulfilling the inclusion criteria
Duration of study- 28 days
Follow up during study-
Day 0, Day 7, Day 14, Day 21 & 28 Day from the initiation of the study.
After permission of ICE and BORS- Prepared case record form will used. Informed consent from patients will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult of any gender All post-operative fistulectomy wound.
排除标准
- •Wound involved with TB, malignancy
- •Infections like HIV, HbsAg Syphilis
- •Uncontrolled Diabetic wound.
结局指标
主要结局
- Assessment of Relief in symptoms of Bhagandara such as Shool, Strava, Shotha, Sparshasahatva and gandha
时间窗: - Baseline, Day 7, Day 14, Day 21 and Day 28
次要结局
未报告次要终点