Comparative clinical study of yava and yavaka based pathya ahara kalpana in the management of madhumeha W.S.R. to Diabetes mellitus type 2.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in the objective parameters-F.B.S.,P.P.B.S., Urine - Routine and Microscopic examination, Lipid Profile, LFT, RFT from baseline value.
研究概览
简要总结
Madhumeh is controlled by regular and proper diet followed by proper medicines in ayurveda and various aahar preparations are mentioned as pathya in which and yavaka pathya ahara kalpana are one among them.various studies have been undertaken to observe the efficacy of yava and yavaka indidivually but studies to compare the clinical efficacy between yavakaand yava on madhumeha has not been done yet.
AIM : To compare the efficacy two groups i.e yava and yavaka ahara kalpana in the management of madhumeh.
*OBJECTIVE:*To conduct randomized clinical trial in order to evalute the efficacy of Yava(Hordeum vulgare linn.) and Yavaka ( Avena sativa linn.) in madhumeha
Null hypothesis (H0): There is no difference between yava and yavaka ahara kalpana in two groups of madhumeha patients.
Alternate hypothesis (H1): There is difference between yava and yavaka ahara kalpanain two groups of madhumeha patients.
Study design: Study type- Prospective, randomized, two arm clinical trial, Phase of clinical trial- Phase – 2, Number of groups- Two, Number of patients - 60, Duration : 18 months
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Fasting Blood Sugar (FBS) in the range of 126-180 mg/dl, Post Prandial Blood Sugar (PPBS) in the range of 140 – 250 mg/dl.
- •Type 2 Diabetes Mellitus Presence of cardinal symptoms of Madhumeha as described in Ayurvedic texts.
排除标准
- •Patients of Type 1 Diabetes.
- •Patients of Type 2 Diabetes who are on insulin therapy.
- •Patients having any serious illness like coronary artery disease, malignancy, kidney failure, neuropathy etc.Pregnant women and lactating mother.
结局指标
主要结局
Changes in the objective parameters-F.B.S.,P.P.B.S., Urine - Routine and Microscopic examination, Lipid Profile, LFT, RFT from baseline value.
时间窗: 4 weeks
次要结局
- Changes in the clinical symptoms of Mahdumeha((Type 2 diabetes mellitus))
研究者
Jyoti khinchi
National institute of Ayurveda