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临床试验/CTRI/2023/06/053991
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)

Tilak Ayurved Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年7月7日最近更新:

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

申办方类型
Research institution and hospital

研究点 (1)

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