A comparative clinical study to determine the efficacy of Bhudhatrayadi yoga and Metformin in the management of Madhumeha with special reference to type II Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Principal
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bahu ashee ------ Polyphagia
研究概览
简要总结
I would like to publish my trial after completion of the trial as soon as possible.This study is a randomised open clinical trial comparing the safety and efficacy of Bhudhatrayadi yoga and Metformin for 12 weeks in 30 patients with type II Diabetes mellitus . 30 patients will be randomly divided in two groups of 15 patients in each group . Patients will be selected from IPD/OPD of R.G.G.P.G. Ayurvedic College and Hospital paprola , Himachal Pradesh , India .
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate in the trial .
- •Patients between the age group of 30-65 yrs will be selected for the study.
- •Patients who present with sign and symptoms of Madhumeha as described in classical texts and fulfill the diagnostic criteria .
- •F.B.S. – 150 to 250 mg/dl P.P.B.S. – 200- 350 mg/dl HBA1C – > 6.5% to 8 %.
排除标准
- •1.Patients Below the age of 30yrs and above the age of 65yrs.
- •2.Patients with Type I and Gestational Diabetes .
- •3.Patients having complications of Diabetes like Nephropathy, Renal Disease , Retinopathy or Cardiac Disease .
- •Patients suffering from other major illness like C.A. or P.T.B. or any other condition considered to be unfit for enrollment in the trial .
结局指标
主要结局
Bahu ashee ------ Polyphagia
时间窗: Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )
Kar-pada-daha ------ Burning sensation in hands and feet.
时间窗: Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )
Relief in following symptoms:
时间窗: Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )
Prabhoot mutrata ------ Polyuria
时间窗: Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )
Alsaya ------ Lethargy.
时间窗: Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )
Pipasa ------ Polydipsia.
时间窗: Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )
Aavilmutrata ----- Turbidity of urine.
时间窗: Patients will be assessed after 4 weeks, 8 weeks and at the end of trial ( i.e. 12 weeks )
次要结局
- To assess the efficacy of Bhudhatrayadi yoga in improving general well being(12 weeks)