跳至主要内容
临床试验/CTRI/2023/11/059684
CTRI/2023/11/059684尚未招募2/3 期

An Open Label Double Arm Clinical Study to Compare the Effect of Gomutra Siddha Apamarga Pratisaraniya Ksharakarma and Udaka Siddha Apamarga Pratisaraniya Ksharakarma in Abhyantara Arshas.

Government Ayurveda Medical College Bengaluru1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年11月25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
40
试验地点
1
主要终点
shrinkage of haemorroidal mass

研究概览

简要总结

This is an open label double arm clinical study to compare the effect of Gomutra Siddha Apamarga Pratisaraniya ksharakarma and Udaka Siddha Apamarga Pratisaraniya Ksharakarma in Arshas.

Group A Comprising of 20 patients of internal haemorrhoids will be subjected to Gomutra Siddha Apamarga Pratisaraniya ksharakarma

Group B Comprising of 20 patients of internal haemorrhoids will be subjected to Udaka Siddha Apamarga Pratisaraniya Ksharakarma

Patients of both group will be observed for 21 days of followup period.

primary outcome will be shrinkage of haemorrhoidal mass and secondary outcomes will be cessation of bleeding per anum , cessation of mucoid discharge per anum , relief of pruritis ani .

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
19.00 Year(s) 至 69.00 Year(s)(—)
性别
All

入选标准

  • Patient above 18 and below 70 years of age.
  • Patients with clinical features of 1st and 2nd degree haemorrhoids.

排除标准

  • Associated with any other anorectal diseases Pregnancy and Lactating women Fecal incontinence Known case of HBV, HCV & HIV infection Uncontrolled Diabetes mellitus 1 and 2 Contraindicated for kshara karma as per Ayurveda.

结局指标

主要结局

shrinkage of haemorroidal mass

时间窗: 21 days

次要结局

  • cessation of bleeding per anum(cessation of mucoid discharge per anum)

研究者

发起方
Government Ayurveda Medical College Bengaluru
申办方类型
Government medical college

研究点 (1)

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