A Controlled Clinical Study of Mustadi Kashaya and Metformin in Prameha Purvarupavastha with special reference to Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To decreases the blood sugar level fasting and post prandial and HbA1c in Prediabetes After oral administration of Mustadi Kashaya for 90 days.
研究概览
简要总结
Prediabetes, also called as intermediate hyperglycemia, is a stage which is characterized by blood glucose levels which are above normal but below the threshold defined for diabetes or having impaired glucose tolerance.
Prediabetes were more frequent in urban than rural areas. In many states with a lower human development index, the ratio of diabetes to prediabetes was less than 1.
Diagnosis of Prameha is confirmed with the help of criteria for diagnosis of DM. Therefore criteria for diagnosis of Pre-diabetes can be beneficial to diagnosis of Prameha Purvarupavastha and help to specify the diagnostic criteria of Prameha Purvarupavastha. Prediabetes being in co-relation with Prameha purvarupavastha. This kalpa can be successfully used in treating this condition of Prediabetes.
So considering these points, the study will be undertaken to evaluate the role of Mustadi Kashaya in the management of patients of Prameha purvarupavasatha. The efficacy of Mustadi Kashaya will be examined by comparing it with the effect of metformin. Hence, a controlled clinical study would be undertaken.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Signs and symptoms of Prediabetes and that of Prameha Purvarupavastha.
- •Newly diagnosed with Prediabetes (IFG between 100-125 and PPBS 140- 199)
- •Not suffering from any other chronic infections including HIV.
- •Having HbA1c between 5.7 to 6.4%.
排除标准
- •Age below 18years & above 65 years
- •Pregnant & lactating mothers.
- •Prior use of medication to treat diabetes except gestational diabetes
- •Have been diagnosed with diabetes by result of IFG more than or equal to 126mg/dl.
- •Patients having complications such as vasculopathy, nephropathy, retinopathy and neuropathy.
- •Patients having other systemic complications like hepatic, renal and cardiac problems.
- •Patients having poorly controlled blood pressure.
- •Pregnant and lactating females not included in this study.
结局指标
主要结局
To decreases the blood sugar level fasting and post prandial and HbA1c in Prediabetes After oral administration of Mustadi Kashaya for 90 days.
时间窗: 0 day (1st visit), 30th day (2nd visit). 91st day ( Last follow up)
次要结局
- To decreases the symptoms of Prameha Purvarupavastha with special reference to Prediabetes.(0 day (1st visit), 30th day (2nd visit). 91st day ( Last follow up))
研究者
Dr Sneha Sudhakar Kamre
Shri Saptashrungi Ayurved Mahavidyalaya, Nashik