A Prospective, Randomised, Placebo - controlled, Double blind trial to Evaluate The Safety and Efficacy of a Proprietary Ayurveda Supplement Glucose & Metabolic Support in The Management Of Type 2 Diabetes Mellitus And Pre-Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
Group A: 30 Diabetes Mellitus type 2 subjects with Oral Hypoglycemic Agent, Metformin 500 mg twice a day before meals and Placebo identical with Investigational product 1 tab three times a day after meals with warm water along with standard diet, lifestyle and yoga protocol.
Group B: 30 Diabetes Mellitus type 2 subjects with Oral Hypoglycemic Agent Metformin 500 mg twice a day before meals and Glucose and Metabolic support three times a day after meals with warm water along with standard diet, lifestyle and yoga protocol.
Group C: 30 Pre - Diabetes Mellitus type 2 subjects: Glucose and Metabolic support 1 tab twice a day after the meals with warm water with standard diet, lifestyle and yoga protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic Participants (Groups A & B): Newly diagnosed type 2 diabetes mellitus Diagnosed within 3 months of time HbA1c more than 6.5% and less than 9% Prediabetic Participants (Group C): Known pre-diabetics for more than 1 year HbA1c between 5.7% and 6.5% No systemic comorbidities like cardiovascular disease, renal impairment, or hepatic dysfunction.
- •No evidence of significant complications of diabetes (e.g., retinopathy, nephropathy, neuropathy).
排除标准
- •Previously diagnosed Type 1 or Type 2 DM on insulin treatment Secondary diabetes due to other conditions (e.g., pregnancy, Cushing’s syndrome, pancreatitis) Pregnant and lactating mother History of gestational diabetes Concurrent use of other Ayurvedic or herbal medications for diabetes during past 6 months Subjects who have completed participation in any other clinical trial during past 6 months.
研究者
Dr Keertan M S
KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya