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临床试验/CTRI/2024/06/069468
CTRI/2024/06/069468尚未招募Phase 3 4

A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Doorvadi Malahara Over Shaala Malahara In The Management Of Parikartika With Special Reference To Acute Fissure In Ano

未提供1 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15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Healing of the fissure(Ulcer)

研究概览

简要总结

This  study is randomised comparative clinical study to evaluate the efficacy of  Doorvadi Malahara over Shaala Malahara in the management of Parikartika with special reference to Acute Fissure in Ano that will be conducted in BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur 586109 Karnataka India

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 having classical features of Acute Fissure in Ano, namely a longitudinal ulcer in the anal region along with any one or more of the following features: excruciating pain in the anal region during and after defecation, bleeding per anum, constipation, burning sensation and presence of sphincter spasm will be selected.
  • Acute solitary fissures.

排除标准

  • Patients with K/C/O Ulcerative colitis, Syphilis, Crohns disease, Inflammatory bowel disease and other systemic disease pertaining to rectum and anal canal.
  • Acute multiple fissures will be excluded from the study.
  • Patient with chronic fissure in ano, Ca of rectum, Ca of anal canal, fistula in ano, haemorrhoids or any other ano rectal diseases.
  • Systemic disorders such as diabetes, tuberculosis.
  • Patients suffering from conditions like HIV, HBsAg and HCV positive patients.

结局指标

主要结局

Healing of the fissure(Ulcer)

时间窗: 21 days

Relieving of Pain and Burning sensation

时间窗: 21 days

次要结局

  • Relieving of Tenderness, Sphincter spasm and Bleeding per anum(21 days)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Shweta T Vambashe

BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur

研究点 (1)

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