Evalutaion of Comparative Efficacy of Salmusta Yoga versus Tablet Metformin in the management of Diabetes mellitus type II Madhumeha A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess and compare the efficacy of salmusta yoga followed by metformin over reduction of fasting and postprandial blood sugar level
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC , MGACHRC, Salod Hirapur Wardha and CTRI registration will be done. After selection each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trials is a randomized open label standard control equivalence clinical trial. It will be include 60 days treatment period and at day follow up period 0th , 30th and 60th days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 31.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to Participate with written informed consent Age group 31 to 60 years of either gender Criteria for diagnosis DM by American Diabetes Association Fasting blood sugar level FBS greater than or equal to 126mg per dl upto 375mg per dl and or Postprandial Blood Sugar Level PPBS greater than or equal to 200mg per dl upto 500mg per dl Newly Diagnosed cases.
排除标准
- •Known cases of Insulin Dependent Diabetes mellitus and those who are under Insulin therapy Patients with Chronic Diabetes complications like Nephropathy Neuropathy and Retinopathy Patients with juvenile diabetes Pregnant and Lactating women.
结局指标
主要结局
To assess and compare the efficacy of salmusta yoga followed by metformin over reduction of fasting and postprandial blood sugar level
时间窗: at baseline 30 days and 60 days
次要结局
- Comparison and Assessment of efficacy of Salmusta Yoga followed by metformin over reduction of fasting and postprandial blood sugar level(30 days and 60 days)
研究者
Diksha Gaikwad
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra