A comparative clinical evaluation of kampillakadi yoga and metformin in the patients of type 2 diabetes Mellitus vis a vis madhumeha

Department of Kayachikitsa Faculty of ayurveda1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2025年2月10日最近更新: 2025年10月23日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 70
试验地点: 1
主要终点: polyuria

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Aim

To clinically evaluate the Antidiabetic effect of Kampillakadi Yoga in the patients of Type 2 Diabetes Milletus vis-Ã -vis Madhumeha.

Objectives

To assess the trial response of Kampillakadi Yoga on subjective and objective parameters in patients of Madhumeha.

To assess the trial response of Metformin on subjective and objective parameters in patients of Madhumeha.

To compare the safety and efficacy of the trial drug with parallel control group i.e. Metformin

To assess & compare the dimensions of Quality-of-life before and after treatment in both the parallel trial groups.

Plan of study

A total 70 patient having clinical features of Type2DM will be selected from OPD and IPD of Kayachikitsa, S. S. Hospital, IMS, B.H.U, Varanasi after thorough history taking, clinical and laboratory examination. Patients of different age groups of either sex & socio-economic status will be selected, on the basis of inclusion and exclusion criteria. Most of the patients come to this hospital directly, while some of them are referred cases from other medical centers or from local doctors.These selected patients will be recruited in to following two groups .

GROUP A (Ayurvedic intervention) Treated with Ayurvedic formulation i.e. Kapillakadi yoga- 2 vati (of 500 mg each tablet) TDS with plane water after meal.

GROUP B (Control group), Treated with modern drug i.e. Metformin- 500mg BD after meal.

Duration of treatment

3 months with Follow ups at 1month interval.

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: 30.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Age between 30 to 60 years Newly diagnosed patient and patient having chronicity less than 3years.
•Patient Body weight- normal to obese.
•(BMI18.5 to 34.9) Patient having no family history of DM Patient having Fasting blood sugar 126 mg/dl to 200 mg/dl Patient having Post prandial blood sugar more than 200mg/dl to 300mg/dl Patient having HbA1c more than 6.5% to 10% Patient fulfilling the diagnostic criteria of American Diabetes Association and as mentioned In Ayurvedic text.

排除标准

•Age less than 30 to more than 60 years Patients having chronicity more than 3years Moderately to grossly obese patients (BMI more than 35) Type 1 diabetes.
•Patient having Fasting blood sugar more than 200mg/dl Patient having Post prandial blood sugar more than 300mg/dl Patient having HbA1c more than 10% Patients on medications other than Metformin Patients on insulin therapy Severe heart liver lung kidney disease or incurable Cancer with complication of diabetes mellitus discussed earlier.