Comparative clinical study to evaluate the add on effectiveness of poly herbal tea in the management Of Diabetes Mellitus Type 2
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Effect of Herbal Tea in the symptoms of Diabetes Mellitus Type 2
研究概览
简要总结
A minimum of 200 subjects fulfilling inclusion criteria will be selected for the study after subjecting them through clinical examination as per the proforma prepared for the study irrespective of gender, religion and socioeconomic status and assigned into following 2 groups by alternative allocation method (1&2)
group 1: 100 subjects who are on Antidiabetic drugs will be continued same dose. if new case is coming under study will be administered with ayurvedic anti diabetic drugs for 3 months.
group 2: 100 subjects will be given karavellakadi herbal tea as part of daily diet twice a day along with antidiabetic drugs which the subject already taking will be continued in same dose.
The stored herbal ingredients will be packed in to tea bags separately, each tea bag weighing 6g, customized tea bag boxes will be made to keep tea bags according to need and distribution.
preparation of herbal tea ( by the subjects under study) : 6g of herbal tea bag is dipped in 50 ml of hot water for 5 minutes (both morning and evening) 7am and 7pm
Data will be collected using case report form designed by incorporatingall aspects ( Ayurvda and modern medicine) for the study. this collected data will be tabulated and analyzed using SPSS version 20 and analyzed using following statistical test
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects fulfilling at least one of the diagnostic criteria 2.Age: 30 year and above 3.subject Irrespective of the gender, religion and socio-economic status 4.subject Willing to give written consent.
排除标准
- •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 a)P.C.O.D b)Thyroid Dysfunction.
- •c)C.A d)Ischemic Heart Disease.
- •7.Known case of Mentally ill.
结局指标
主要结局
Effect of Herbal Tea in the symptoms of Diabetes Mellitus Type 2
时间窗: Effect of Herbal Tea in symptoms of Diabetes Mellitus type 2, after 3 months
次要结局
- Compare effect of Poly Herbal Tea in symptoms of Diabetes Mellitus Type 2 in future(Compare effect of Poly Herbal Tea in symptoms of Diabetes Mellitus Type 2 after 3 months)