Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- BMI (Anthropometric Measurement)
研究概览
简要总结
'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients
详细描述
Diabetes Mellitus is one of the oldest diseases known to men and has been treated with multiple agents,organic and with the current pharmacological advancement,with multiple synthetic drugs as well.
Metformin has been considered first line for the treatment of Type 2 Diabetes, however presents itself with a side effect profile of GI distress, Vitamin B12 deficiency,to name a few.
Vinegar has been used as therapeutic agent for centuries for multiple ailments including diabetes. This study aims to evaluate the combined effects of drug and natural therapy and compare it with conventional therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently diagnosed Type 2 diabetic patients taking metformin 750 mg daily as the oral antidiabetic agent
- •Patients with Hemoglobin A1c in the range of 6.5 to 7.5%
排除标准
- •All newly diagnosed Diabetic Patients requiring a dosage other than 750 mg per day
- •Patients on Insulin Therapy or any drugs for diabetes other than Metformin
- •Pregnant and Lactating women
- •Patients with food allergies to either apple or any source of vinegar
- •Patients unable to communicate efficiently\mentally challenged
- •Type 2 Diabetic patients with any of the complications of long standing uncontrolled diabetes
研究组 & 干预措施
Group 1
Intervention: Metformin Tablet oral 750 mg OD
干预措施: Metformin Oral Tablet (Drug)
Group 2
Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD
干预措施: Metformin Oral Tablet (Drug)
Group 2
Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD
干预措施: Vinegar (Dietary Supplement)
结局指标
主要结局
BMI (Anthropometric Measurement)
时间窗: 12 weeks
Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square
Measurement of Hemoglobin A1c
时间窗: 12 weeks
A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control
Measurement of Fasting Blood Sugar
时间窗: 12 weeks
A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting
次要结局
未报告次要终点
研究者
Dr Momina Abid
Dr Momina Abid
Ziauddin University