A comparative experimental and clinical study to evaluate the hypoglycemic efficacy of two ayurvedic drugs Brahmi (Bacopa monnieri Linn.) and Mandukparni (Centella asiatica Linn.) in patients suffering from madhumeha w.s.r to type-2 diabetes mellitus.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome will be measured based on the clinical outcome measures, bio-chemical outcome measures, safety and tolerability outcome measure to determine and compare the effectiveness and safety of the two-test drugs brahmi and mandukparni for the treatment of madhumeha (type 2 diabetes mellitus)
研究概览
简要总结
The present study will be single blind double arm interventional clinical study with two groups of patients having newly diagnosed type2 diabetes mellitus in the IPD and OPD of the hospital at the Institute of Post Graduate Ayueveda Education and Research at SVSP, Government of West bengal, Kolkata-700009. The subjective and objective parameters will be assessed with data compilation and stastistical analysis will be carried out. The research aims to provide insights into the safety and efficacy of both the test drugs in managing type 2 Diabetes mellitus ,both in animal models and human subjects. The parameters and outcome measures will help assess and compare the potential of both the test drugs for future clinical applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Blood sugar – Fasting greater than 126mg/dl to less than or equal to 200mgdl PP- Greater than 200mgdl and less than or equal to 350mgdl Glycated haemoglobin greater than 7 percentage and less than 10 percentage Recently diagnosed less than 6 month cases of Type 2 diabetes mellitus not taking any diabetes medications.
排除标准
- •Age below 30 years and above 65 years Blood sugar Fasting less than or equal 126mgdl and greater than 200mgdl PP less than or equal to 200mgdl and greater than 350mgdl Glycated haemoglbin less than or equal to 7 percentage and greater than or equal to 10 percentage Malignant and accelerated hypertensive CVS disorder Pregnant women and planning to be pregnant within 6 months Lactating mother Secondary diabetes mellitus Patients undergoing regular treatment for Diabetes or any other severe illness CNS disorders Type 1 diabetes mellitus Comorbid conditions like ESLD ESRD Organ dysfunction multiple chronic conditions.
结局指标
主要结局
The primary outcome will be measured based on the clinical outcome measures, bio-chemical outcome measures, safety and tolerability outcome measure to determine and compare the effectiveness and safety of the two-test drugs brahmi and mandukparni for the treatment of madhumeha (type 2 diabetes mellitus)
时间窗: 56 days (8 weeks)
次要结局
- The effects of both the test drugs changes the quality of life to be assessed after completion of the treatment.(56 days (8 weeks))