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临床试验/CTRI/2021/07/034782
CTRI/2021/07/034782尚未招募2/3 期

Comparative Study of Anal Dilatation with External Lateral Sphincterotomy in the Management ofFissure in Ano.

PDEAS College of Ayurved and Research Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月8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
60
试验地点
1
主要终点
To compare the efficacy of anal dilatation and

研究概览

简要总结

Anal Fissure is one of the major causes for pain in anal region.In this study. Patients attending OPD/IPD of Shalya and suffering from acute fissure will be recruited from age group 18-60 years.Screening of subjects according to baseline assessment & inclusion & exclusion criteria.A well written informed consent will be obtained from all the participants explaining the details about the treatments or procedure done on them. Aim of study is To compare the efficacy of anal dilatation and external lateral sphincterotomy in fissure. Anal dilatation and External lateral anal sphincterotomy are the intervention.External Lateral anal sphincterotomy has been accepted as the gold standard treatment for chronic fissures. Sushruta had also mentioned therapeutic procedures.Shastra karma for fissure. Regarding Parikartika , a lot of previously work has been done on various local as well as oral medication like Jatyadi Ghruta, Pichh Basti, Vataharan Taila, Basti Nirgundyadi Malhar, Dashmuladi Kwath etc.. But it has been observed that Anal dilatation and External lateral anal sphincterotomy has not been been studied earlier that’s why this study would be having newer outcome in the management of fissure in ano

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Patients of within age of
  • 60 year of either sex. The patient who are having classical signs and symptoms of acute fissure in ano will be selected for present clinical study. Patient are ready to give informed consent. After screening for covid 19 in covid-19 screening opd , pt will be selected.

排除标准

  • Patients having Parikartika (Fissure-in-ano) secondary to Ulcerative colitis, Syphilis, Crohn’s disease, Tuberculosis and Ca of rectum and anal canal.

结局指标

主要结局

To compare the efficacy of anal dilatation and

时间窗: It will assessed on 15 day

external lateral sphincterotomy in fissure

时间窗: It will assessed on 15 day

次要结局

  • To get relief from fissure in ano(To relief from fissure in ano within 30 days)

研究者

发起方
PDEAS College of Ayurved and Research Center
申办方类型
Private medical college

研究点 (1)

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