CTRI/2023/01/048911尚未招募2/3 期
Randomised Controlled Clinical Trial to compare Yashtyadi Malahara with Nifedipine Ointment as a local intervention in Parikartika(Fissure in ano )
Tilak Ayurved Mahavidyalaya Pune1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年1月15日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Reduction in pain ,
研究概览
简要总结
Ano rectal disorders are common and increasing in incidence . In consideration of severity of symptoms of fissure in ano , one needs to advocate treatment with suitable medications which is cost effective and easily available and more potent to relieve the pain and spasm . For this purpose yashti and tila kalka is taken as a trial drug. Interventional drug is administered with primary outcome of pain management and wound healing in fissure in ano . local application of malahara will be done for period of 20days 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
- •1 All the clinically diagnosed patients of parikartika.
排除标准
- •1 Uncontrolled systemic diseases 2 Known case of CA Rectum 3 Severely immunocompromised 4 Patients having parikartika secondary to ulcerative colitis , syphilis , chrons disease ,TB.
结局指标
主要结局
Reduction in pain ,
时间窗: Baseline , day 1st , 7th , 14th , 20th day
Healing of wound at anal verge ( tear ) will be assessed
时间窗: Baseline , day 1st , 7th , 14th , 20th day
次要结局
- Rakta strava ( Pr Bleeding) assessment(After 20days)
研究者
研究点 (1)
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