A Randomized controlled clinical trial to evaluate add on effect of Eladi vati with oral hypoglycemic agent metformin+Glimepiride in type 2 Diabetes Mellitus .
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the add on effect of Eladi Vati with oral hypoglycemic agent
研究概览
简要总结
Nowadays due to the Sedentary life style, Stress and irregular dietary
habits the ratio of Prameha is increasing day by day in society and the
availability of patients is more.
Since Eladi Vati possesses all properties of potent medicine useful for
Prameha Chikitsa.
To evaluate add on effect of Eladi Vati in Prameha with Oral
Hypoglycemic Agent this study designed.
All contains of trial drug has properties like Kledaghna,
Medodushutighna, Rasayana, Kaphghna, Medodhatwagni Vardhan
properties.
Eladi Vati is mentioned in Harit Samhita having all the properties may
revert the pathogenesis of Prameha.
All the ingredients present Eladi Vati are easily available.
Therefore, this formulation was chosen for present study.
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
- 35.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •Two or more symptoms of Prameha Daurbalya, Kshudhavridhdhi, Pipasatrivridhdhi, Prabhutamutrata, Naktamutrata, HastaPadatala Daha
- •Age group between 35 to 65 years.
- •Cases of both Gender will be included.
- •Known case of Type-2 DM, Non insulin dependent diabetes mellitus.
- •Patient having HbA1C upto
- •Patient with fasting blood sugar up to 250 mg/dl and post prandial blood sugar up to 350 mg/dl
- •Patient taking Metformin+ Glimepiride drug since minimum 6 Months.
排除标准
- •1.Known case of Insulin Dependent Diabetes Mellitus (IDDM) and those who are under insulin therapy.
- •2.Known case of Renal Disorders like Chronic kidney disease and Acute kidney diseases.
- •3.Known case of acute complications Hyperglycemic & hypoglycemic coma, Ketoacidosis and related complication and Infections like gangrene.
- •Patients suffering from all major systemic disorders AIDS , TB.
- •Diabetes Mellitus developed due to secondary cause such as infective pancreatitis, drug induced auto immune antibodies.
- •Pregnant & lactating women.
结局指标
主要结局
To evaluate the add on effect of Eladi Vati with oral hypoglycemic agent
时间窗: 90 days with follow up on | 30th, 60th and 90th day.
(Metformin + Glimepiride) in Type ll DM for 3 months.
时间窗: 90 days with follow up on | 30th, 60th and 90th day.
次要结局
- To observe adverse effects if any.
研究者
Dr Akshay Bhagwan Waghmare
PDEAs collage of Ayurveda and research centre nigdi pune