CTRI/2023/06/053991尚未招募2/3 期
Randomised controlled clinical trial to compare bahubeeja malhara with nifedipine ointment as a local intervention in parikartika(fissure in ano)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Healing of wound at anal verge(tear) will be assessed
研究概览
简要总结
Ano rectal disorder are common and increasing in incidence. Inconsideration of severity of symptoms of fissure in ano,one need to advocate treatment with suitable medication which is cost effective and easily available and more potent to relieve the pain and spasm. For this purpose bahubeej kalka and sikta is taken as trial drug. Interventional drug is administered with primary outcome of pain management and wound healing in fissure in ano. Local application of malahar will be done for a period of 21 days along with sitz bath.
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •all clinically diagnosed patients of parikartika.
排除标准
- •Uncontrolled systemic disease Known case of CA rectum Severely immunocompromised Patient having parikartika secondary to ulcerative collitis,syphilis,TB.
结局指标
主要结局
Healing of wound at anal verge(tear) will be assessed
时间窗: Baseline,day 1st,7th,14th,21st
Reduction of pain
时间窗: Baseline,day 1st,7th,14th,21st
次要结局
- Raktastrav(PR bleeding) assessment(after 21 days)
研究者
研究点 (1)
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