An Open label, Single arm, clinical Study to evaluate efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving QOL
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar.
研究概览
简要总结
An Open label, Single arm, clinical Study to evaluate efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving QOL. The objective of current study is to evaluate the efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving Quality of Life.Participants as below will be recruited in 1:2 ratio: Prediabetics (borderline) and Confirmed diabetics cases concomitantly taking Oral Hypoglycaemic Drugs. Primary outcome will beTo evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar. Secondary outcome will be To evaluate if there is reduction in Body mass index (BMI) and any notable changes in haematology and biochemistry profile leading to improvement in quality of life.
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
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged more than 18 years of age who agree to participate in the study willing and able to answer the questionnaire and give their written informed consent.
- •For Diabetics-Participant with initial HBA1c value 6.5percent and above.
- •Patients who are under the treatment of oral antidiabetic drugs.
- •Patients who have not changed their medication in the last three months prior to signing up for the study.
- •(However, dosage modifications are allowed).
- •For prediabetics: Participant with initial HBA1c value 5.7 to 6.4 percent.3) Known cases of pre-diabetes with fasting blood sugar not exceeding 130mg/dl with obesity and having family history of diabetes.
- •Subjects with Body Mass Index (BMI) more than 27 kgper m2 and less than 45 kgperm2.
排除标准
- •Women with regular menstruation history having missed periods.
- •Confirmed cases of pregnancy and lactation.
- •Patients who are on insulin therapy.
- •Patients with a history of chronic illness type 1 diabetes and /or history of ketoacidosis.
- •Patients with Insulin use and or or hyperosmolar hyperglycaemic state 6) Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies).
结局指标
主要结局
To evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar.
时间窗: At visit 1 (screening & baseline), visit 2 (at week 4), visit 3 (at week 8), visit 4 (at week 12)
次要结局
- To evaluate if there is reduction in Body mass index (BMI) and any notable changes in haematology and biochemistry profile leading to improvement in quality of life.(visit 1, 2, 3 and 4)
研究者
Srinivasa Yathapu Reddy
Dabur India Limited