A Two Arm, Randomized, controlled, double blinded Study on Ayurvedic management of Type-2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Fasting Blood Sugar
研究概览
简要总结
Diabetes has been on the rise in India. There is now more than ever, aneed to have a comprehensive cost-effective mass health care strategy toaddress the disease and its associated complication. Apart from the managementof Diabetes, it also becomes vital to screen and identify the high-riskpopulation and put in place appropriate interventions / strategies to preventprogression to diabetes mellitus.
S-VYASA (a deemed University under section 3 of UGC act 1956), is a NAACA+ accredited University established in 2002 with a vision to make Yoga asocially relevant science. As a part of our mission, we have scientificallyvalidated Yoga practices and have been able to scientifically develop andadminister personalised disease specific Yoga modules. In 2016, our initiative ’Stop Diabetes Movement’ was adopted bythe Ministry Of AYUSH as a national program – Niyantritha Madhumeha Bharatha [NMB] – an initiative to treat andprevent incidence of Diabetes mellitus.
Under the national scheme NMB, we have screened 2,40,968 adults forDiabetes Mellitus across the country. Under the same scheme diagnosed diabeticand high-risk individuals were treated with Yoga and were followed up for 3months to understand the efficacy of Yoga, to treat diabetes and to preventconversion of pre-diabetics to diabetics. In continuation, we here propose to study efficacy and mechanism ofaction of Ayurveda and Yoga in prevention & management of Diabetes throughAyurveda. Standardized ayurvedic formulation, Ayush-82 extract tablet will beused as intervention. The study is funded under the CSR program of Jivanti Welfare andCharitable Trust
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Known / diagnosed Type-2 diabetics picked up from screened population with >60 score on IDRS
- •without hypertension and obesity
- •Those on oral hypo glycemic drugs [any OHA]
- •Subjects with HbA1C ≥ 6.4%.
排除标准
- •Morbid Obesity [BMI ≥ 40 kg/m2]
- •Subjects with conditions such as uncontrolled hypertension (persistent BP > 180/ 100 mm of Hg after two consecutive recordings and also by checking from their earlier medical records) or severe range of obesity [BMI ≥ 40 kg/m2]
- •History of a major/ minor surgery in the past 3 months.
- •History of tuberculosis within past 3 years.
- •History of head injury, neurological or psychiatric disorder in the past
- •Pregnancy and lactation.
结局指标
主要结局
Fasting Blood Sugar
时间窗: Baseline | 3 months | 6 months
HbA1c
时间窗: Baseline | 3 months | 6 months
次要结局
- Lipid Profile (LDL, HDL, VLDL, TC, TG)(Liver Function (SGOT, SGPT))
