Efficacy and safety of Ayurvedic polyherbal decoction Varadi Kashaya to reduce Glycated Hemoglobin (HbA1c) in patients of Type 2 Diabetes Mellitus as compared to standard of care in Bharati Ayurved Hospital Pune, A randomized controlled proof of concept trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine Efficacy of Varadi Kashaya to achieve glycemic control in 90 days as compared to standard of care in type 2 Diabetes Mellitus patients
研究概览
简要总结
The current study determines the efficacy of a poly herbal formulation Varadi Kashaya (decoction) expounded in the classic text of Charak Samhita. This study also compares the Investigational drug (ID) with standard of care and its effectiveness in glycemic control. Both the groups will be tested for effect on insulin resistance, lipid dysfunction and safety. Although it is a non inferiority trial, if Varadi Kashaya is found to be superior than the Standard of care to achieve glycemic control it will be reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed patients with HbA1c more than 6.5 % up to 8 % not taking any standard of care Patients from all socioeconomic condition.
排除标准
- •Patient involved in any diabetic trial in recent time.
- •Patients having any hemolytic conditions.
- •Known case of Gestational diabetes.
- •Known case Patients of type 1 Diabetes mellitus.
- •Known case of Diabetes Mellitus associated with systemic viral/bacterial infections like HIV, Hepatitis, Tuberculosis and Malignancy etc.
结局指标
主要结局
To determine Efficacy of Varadi Kashaya to achieve glycemic control in 90 days as compared to standard of care in type 2 Diabetes Mellitus patients
时间窗: DAY - 0, 90
次要结局
- To determine efficacy in rate of Varadi Kashaya to achieve glycemic control in comparison to standard care in type 2 Diabetes Mellitus patients(DAY - 0, 30, 60, 90)
- To determine efficacy of Varadi Kashaya on insulin resistance in type 2 Diabetes Mellitus patients(DAY- 0, 90)
- To determine efficacy of Varadi Kashaya on Lipid profile in type 2 Diabetes Mellitus patients(DAY - 0, 90)
- To determine the safety of Varadi Kashaya(DAY - 90)
研究者
Advait Murli Menon
Bharati Vidyapeeth (Deemed to be University) College of Ayurved