CTRI/2023/03/050203已完成2 期
Efficacy of Kokilaksha Kshara in Pittashaya Ashmari W.S.R to Cholelithiasis – A Single Arm Clinical Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- 1)Reduction in size,
研究概览
简要总结
This is a Single Arm Clinical Trial studying the Efficacy of Kokilaksha Kshara in patients with Cholelithiasis, that will be conducted in All India Institute of Ayurveda, New Delhi, India. The Primary outcome measures will be reduction in size of gall bladder stones, reduction in no. of gall bladder stones, and improvement in gall bladder status with use of Kokilaksha Kshara for 45 days . The secondary outcomes will be improvement in patients Symptoms relating to cholelithiasis (observations based on different scales) at a period of 45 days.
Null hypothesis was accepted
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age:- Patient more than 18yrs and less than 60yrs.
- •Gallbladder Stones size :- <15mm.
- •All the cases presenting with the clinical signs and symptoms of cholelithiasis diagnosed with USG findings.
- •Asymptomatic Patient diagnosed with cholelithiasis through USG.
排除标准
- •Acute Cholecystitis, complicated cases of cholelithiasis.
- •Patient suffering from chronic illness related to CVS, renal, hepatic and GIT.
- •Pregnant women, Lactating mothers.
- •Patient taking drugs affecting bile acids or serum lipids eg.
- •hypolipidaemic drugs, OC pills, phenobarbitone.
结局指标
主要结局
1)Reduction in size,
时间窗: 45 days
2)Reduction in no. of gallbladder stones and
时间窗: 45 days
3)improvement in the gallbladder status with use of Kokilaksha Kshara
时间窗: 45 days
次要结局
- Improvement in patient’s Symptoms (nausea, fever,flatulence dyspepsia) based on observations using different scales) relating to cholelithiasis .(from 1st day upto 45th days)
研究者
研究点 (1)
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