An Epidemiological Study to identify Santarpaṇa Hetu and to assess the Quality of Life in Patients of Madhumeha (Diabetes Mellitus) and Therapeutic Trial to Evaluate the Efficacy of NyagrodhÄdi Vaá¹Ä« and Mehamudgara Vaá¹Ä«
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Developed low cost management in Madhumeha (Diabetes) for symptomatic relief in Madhumehi (Diabetic) patients.
研究概览
简要总结
A Randomised clinical trial has been designed to assess the efficacy of ‘NyagrodhÄdi Vaá¹Ä«â€™ and ‘Mehamudgara Vaá¹Ä«â€™ in the management of Madhumeha (Type-2 Diabetes Mellitus). Total 120 patients of Madhumeha (Type-2 Diabetes Mellitus) will be selected from Diabetic O.P.D. and O.P.D. of Roganidana Evam Vikrti Vijnana department of N.I.A. and randomly divided in 2 groups having 60 patients each. Group A (60 Patients) will be received NyagrodhÄdi Vaá¹Ä« , 6 gm /day in 3 divided doses (4 Vaá¹Ä« TDS, each Vaá¹Ä« of 500mg) for 6 weeks. Group B (60 Patients) will be received Mehamudgara Vaá¹Ä« , 1 gm /day in 2 divided doses (2 Vaá¹Ä« BD, each Vaá¹Ä« of 250mg) for 6 weeks. Patients will be reviewed on 15th, 30th and 45th day after their inclusion in trial. Assessment of effects of the therapy will be done on the basis of various subjective and objective criteria. Any change in sign and symptom will be noted. Laboratory investigation will be repeated after the completion of the trial and the result will be documented. Data will be analyzed using appropriate statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients of type-2 diabetes fulfilling the criteria of American Diabetes Association (ADA) for Diabetes Mellitus.
- •Patients of age group 30 years – 70 years of either gender.
- •Patients who shows clinical signs and symptoms of Madhumeha (type- 2 DM).
排除标准
- •Patient of IDDM (type-1 D.M.) Complicated cases of Diabetes Mellitus.
- •Type-2 Diabetes patient on insulin therapy.
- •Patients with Gestational Diabetes Mellitus and lactating mother etc.
- •Patients with Fasting blood sugar more than 200 mg/dl and post prandial blood sugar more than 300 mg/dl.
- •Diabetic patients with severe complications like cardiovascular diseases, Nephropathy, Retinopathy, Diabetic foot etc.
- •Diabetes due to endocrinopathies e.g. Phaeochromocytoma, Acromegaly, Cushing’s syndrome, Hyperthyroidism etc.
- •Patients with genetic syndromes associated with D.M. like Down’s syndrome,Klinefelter’s syndrome, Turner’s syndrome.
结局指标
主要结局
Developed low cost management in Madhumeha (Diabetes) for symptomatic relief in Madhumehi (Diabetic) patients.
时间窗: 6 weeks
次要结局
- Devoloped awareness about Santarpana Hetu(Unhealthy diet and Sedentary lifestyle) in Diabetic patients.(6 weeks)