A Randomised Comparative Clinical Study Of Nia Vr ointment And Povidone Iodine Ointment in The Management Of Post Operative Transphincteric Anal Fistula Wound
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall improvement to the wound
研究概览
简要总结
Participants attending OPD and IPDof NIA Shalyatantra department satisfying the selection criteria will be selected. All the participants who voluntarily agree to participate and provide informed written consent for participation will be recruIted in tHe study .
Total 60 participants will be selected after detail examination and divided in 2 groups of 30 patients as per study protocol.All procedures will be executed under aseptic precaution. Patient will be kept for 3 days in post operative days
assessment of the outcome will be on 7, 14 ,21 28 days Patient will be followed up on every 2 nd week after completion of trial for 2 months
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of post operative partial fistulotomy (Anshik Bhedana) with Ksharasutra application between 20 to 60 yrs of age will be included in this study.
- •Having no any other local or systemic ailment requiring active treatment.
排除标准
- •Intersphincteric Extrasphinctericor Suprasphincteric anal fistula Patients with other concurrent diseases requiring active treatment.
结局指标
主要结局
Overall improvement to the wound
时间窗: 4 weeks
wound status will be assesed on the basis of subjective parameter i.e pain and gandha .Objective parameter stava and wound size .
时间窗: 4 weeks
次要结局
- Change in the quality of life of the patient(12 week)