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临床试验/CTRI/2024/07/070264
CTRI/2024/07/070264尚未招募不适用

A randomized controlled clinical study to evaluate the efficacy of yashtimadhu tila kalka ksheera basti in parikartika vis-Ã -vis fissure in ano

Muniyal institute of ayurveda medical sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To relieve pain

研究概览

简要总结

Fissure in ano is the commonest among anorectal disorders. Anal fissure is longitudinal split in anoderm of the distal anal canal which extends from anal verge proximally towards, but not beyond dentate line. Similarly, Parikartika is explained in ayurveda as excruciating cutting pain in the anal region. Every individual suffers from proctological symptoms at least once in their lifetime.

Yashtimadhu ghrita Matra Basti is a Shamana Basti and it helps in wound healing. Yashtimadhu Tila Kalka Ksheera Basti on the other hand not only helps in wound healing but also acts as Shodhana Basti due to its Matra, thus preventing or treating Pureeshavaha Sroto Vikaras thereby regulating sphincter tone and preventing constipation. Yahtimadhu Tila Kalka Ksheera Basti is mentioned in Basti Vyapath.

This is a clinical study between study group and control group. Minimum 40 clinically diagnosed patients of Parikartika (fissure in ano) are selected based on inclusion and exclusion criteria. The parameters of signs, symptoms and investigation will be scored on the basis of standard method and will be analyzed statistically. Registered patients will be allotted randomly into two equal groups of minimum 20 patients each A and B.

Twenty subjects of this group will be subjected to Yashtimadhu Tila Kalka Ksheera Basti ;Dose: 450ml once a day ;Duration: 7 days. Twenty subjects of this group will be subjected to Yashtimadhu Ghrita Matra Basti: Dose: 30ml once a day;Duration: 7days.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

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.Clinically diagnosed case of fissure in ano are taken for the study.
  • 2.Patient of both sexes with age group of 18 to 60years.
  • 3.Patients irrespective of religion, Occupation and economic status.
  • 4.Acute fissure in ano and chronic fissure with acute onset.

排除标准

  • 1.Patients having Fissure-in-ano secondary to Ulcerative colitis, Crohn’s disease, tuberculosis and malignancy of rectum and anal canal.
  • 2.Patients with infectious diseases like HIV& HBsAg. 3.Patients with fissure associated with Hemorrhoids and Fistula-in- ano.

结局指标

主要结局

To relieve pain

时间窗: 4th day

次要结局

  • To cure pain, bleeding, constipation(7days)

研究者

发起方
Muniyal institute of ayurveda medical sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr A R Sumanth Acharya

Muniyal Institute of Ayurveda Medical Sciences, Manipal

研究点 (1)

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