Efficacy of Integrated Ayurveda Protocol in Inadequately Controlled Type 2 Diabetes Mellitus A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose, which leads overtime to serious damage to the heart, blood vessels, eyes, kidneys and nerves. Diabetes affects an estimated 537 million adults worldwide between the age of 20 to 79 (10.5% of all adults in this age range). By 2030, 643 million people will have diabetes globally, increasing to 783 million by 2045. Type 2 Diabetes mellitus(T2DM) accounts for more than 90 – 95% of all patients with diabetes. In epidemiological surveys and as per the American Diabetes Association (ADA), Inadequately controlled T2DM is measured as a glycated hemoglobin level of
7%. An anti-diabetic drug’s therapeutic strategy should be able to stop the advancement of diabetes complications as well as glycaemic control. [v] Because they are successful at lowering blood glucose levels and have the fewest adverse effects, alternative medicines for diabetes have recently gained popularity. If this all-encompassing approach is proven to be successful, it might be safer and better tolerated. Ayurvedic medicine’s importance would also be highlighted by the absence of supporting data, which could spark the start of additional randomized controlled trials. The risk of macrovascular and microvascular problems in T2DM is reduced by glycemic management. Pharmacological treatment and a change in lifestyle are required for good glycemic control to be achieved and maintained. Pharmacological treatment of T2DM has several drawbacks because it can cause hypoglycemia, vitamin B12 deficiency, increased cardiovascular risk, etc. Yoga, Panchakarma 2 therapies, and Ayurvedic food and treatment will all be incorporated into the treatment plan to promote adequate glycemic control and slow the development of problems. Thus, the need of the hour is to study the efficacy of Integrated Ayurveda protocol in comparison to Standard protocol in T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Diagnosed T2DM with chronicity of equal to or less than one year duration 2 Age group between 18 to 50 years 3 Glycosylated hemoglobin (HbA1c) between 7.0 percent to 10.5 percent 4 Subject who submits written informed consent.
排除标准
- •1 Subjects with uncontrolled hypertension (with BP more than or equal to 140/90 mmHg) 2 Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease 3 Subjects with established cases of cerebrovascular accidents such as stroke etc 4 Subjects with any complications of Type 2 Diabetes Mellitus such as retinopathy, neuropathy, nephropathy etc 5 Pregnant and lactating women 6 Subjects not fit for Yoga performance.
结局指标
主要结局
HbA1c
时间窗: 0th 90th day
次要结局
- weight waist circumference FBS PPBS Triglycerides Triglyceride glucose index(weight waist circumference FBS PPBS Urine sugar BMI (Baseline 30th 60th 90th day))
研究者
Dr Asha
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka
