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临床试验/CTRI/2024/08/072438
CTRI/2024/08/072438尚未招募2/3 期

A Randomised Controlled Trial To Evaluate The Effect Of Erandakarkati Yava Ksharasutra In The Management Of Bhagandara (Fistula In Ano)

Parveen Kumar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月26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
30
试验地点
1
主要终点
Complete healing of the fistula tract with healthy granulation tissue.

研究概览

简要总结

Bhagandara  is one of the Ashtamhagada. In modern science, it is correlated with Fistula in ano. the prevalence rate of fistula in ano is 8.6 cases for every 100,0000 populations. Appropriate treatment is based on 3 central tenets namely, control of sepsis, closure of the fistula and maintenance of continence. Ksharasutra technique allows complete healing of the fistula in 94% of patients. Erandakarkati which is abundantly available has been taken for preparing Ksharasutra in this study. It contains a chemical named papain which is alkaloid in nature. Yava Kshara is well known for its Lekhana action. Some study on Erandakarkati based Ksharasutra application has been done previously but more data is required to prove its effectiveness. Therefore, it is planned to evaluate the effect of Erandakarkati Yava Kshara Sutra in the management of Bhagandara.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

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 fulfiling clinical sign and symptoms of Bhagandara.

排除标准

  • HBsAg, HIV-positive patients.
  • Patients suffering from secondary fistulas due to Crohn’s disease, ulcerative colitis, carcinoma, and tuberculosis.
  • Patients having uncontrolled DM & HTN.

结局指标

主要结局

Complete healing of the fistula tract with healthy granulation tissue.

时间窗: 8 weeks

次要结局

  • complete healing of the fistula tract without any re-occurrence(after complete healing of tract patient will be advised to visit 14th and 28th day)

研究者

发起方
Parveen Kumar
申办方类型
Other [(self)]
责任方
Principal Investigator
主要研究者

Parveen Kumar

Sri Jayendra Saraswathi Ayurveda College and Hospital

研究点 (1)

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