CTRI/2025/02/080640已完成Unknown
An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Shuddhi Dr. Madhumeh tablets in patients suffering from Diabetes
Jeena Sikho Lifecare Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月27日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 3. Change in Urine Routine
研究概览
简要总结
An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Shuddhi Dr Madhucare Tablets in patients suffering from Diabetes.
From age 18 years to 65 years of age.
The subjects will take 1 tablet 30 mins before meal two times a day with lukewarm water for the duration of 90 days.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject from 18 to 65 years of age.
- •Subject suffering from Diabetes with Fasting Blood Glucose level below 200 mg/dl.
- •If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •Subject that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
- •Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
排除标准
- •Females that are pregnant, breast feeding, or planning to get pregnant during the study.
- •Subject on insulin.
- •Subject that have participated in any other interventional clinical trial in the previous 90 days.
- •Subject with known sensitivity to any of the constituents of the investigational product.
结局指标
主要结局
3. Change in Urine Routine
时间窗: Day 1, Day 90
Efficacy of Shuddhi Dr Madhucare Tablets
时间窗: Day 1, Day 90
1. Change in HbA1c
时间窗: Day 1, Day 90
2. Change in CBC
时间窗: Day 1, Day 90
次要结局
- study the quality of life by.(1. QOL(SF-36))
研究者
Dr Rakhi Mehra
GS Ayurveda Medical College and hospital
研究点 (1)
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