A comparative clinical study to evaluate the add on effectiveness of sorghum samp (yavanala yusha) and poly herbal tea in the management of diabetes mellitus type II
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 1) FBS
研究概览
简要总结
Sorghum Samp 200ml and Polyherbal tea 50 ml will be given once in morning at 7:30 am and at 7pm respectively as a part of the daily diet in the management of Diabetes Mellitus type II.
A minimum of 250 subjects fulfilling inclusion criteria will be selected for the study after subjecting them to thorough clinical examination as per the Proforma prepared for the study irrespective of gender, religion and socio-economic status and assigned into following 2 groups by alternative allocation method (1&2)
Group 1: 125 subjects who are on Anti diabetic drugs will be continued same dose for 3 months.
Group 2: 125 subjects will be given Sorghum Samp in the morning and Poly Herbal Tea in the evening as a part of daily diet along with Anti diabetic drugs which the subject is already taking will be continued in same dose for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects fulfilling at least one of the diagnostic criteria 2.Less than 2 years of diagnosis 3.Age: 20 – 60 Years 4.Irrespective of the gender, religion and socio economic status 5.Willing to give written consent.
排除标准
- •1.Insulin dependent subjects.
- •2.Known case of Diabetic nephropathy 3.Known case of Ketoacidosis 4.Known case of Cerebrovascular diseases 5.Women in Pregnancy/lactation
- •Subjects with other systemic disorders such as P.C.O.D. Thyroid Dysfunction Carcinoma Ischemic Heart Disease.
结局指标
主要结局
1) FBS
时间窗: 0th day, 30th day, 60th day and 90th day
2) PPBS
时间窗: 0th day, 30th day, 60th day and 90th day
3) HbA1C
时间窗: 0th day, 30th day, 60th day and 90th day
4) Triglycerides
时间窗: 0th day, 30th day, 60th day and 90th day
次要结局
- Weight in kg(BMI)
研究者
Dr K Samudrudu
SDM College of Ayurveda and Hospital Hassan