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临床试验/CTRI/2019/02/017500
CTRI/2019/02/017500已完成不适用

A Randomised control trial for the mechanism of action of Yoga and Ayurveda with Yoga in Type-2 Diabetes mellitus

Jivanti Welfare and Charitable Trust1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年2月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Pro insulin

研究概览

简要总结

1. INTRODUCTION

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 & Yoga. Standardized ayurvedic formulation, Ayush-82 andIntegrated Approach of Yoga Therapy (IAYT) module used previously in SDM willbe used as interventions. The study is funded under the CSR program of Jivanti Welfare andCharitable Trust

Rationale of the study

Many studies have been done on diabetics with yoga intervention. Almost all the studies have aimed looking at the efficacy of yoga on diabetics. There are very few studies which have tried to find out changes at the level of molecular mechanisms. Though the efficacy of the intervention is of utmost importance, having an insight as to how yoga works to be beneficial needs to be explored. Hence we propose this exploratory study to try to find the mechanism of action of yoga in type 2 diabetes. In this study, we are aiming to find the mechanism of action of yoga alone and see synergistic effect of yoga with ayurveda in type 2 diabetes

Aim:

To understand the effect of yoga on the implicated pathway in pathogenesis/ prognosis of type 2 Diabetes mellitus.

Objectives:

1.      To find out the modulation of implicated markers with yoga alone and in combination with Ayurveda as intervention (AYUSH 82 drug extract) in type 2 diabetes.

2.      To elucidate the changes in gene expression due to yoga in type 2 diabetes.

3.      Does Yoga in conjugation with Ayurveda (AYUSH 82 drug extract) have a synergistic effect in alleviating type 2 diabetics?

4.      To propose a model for the mechanism of action of Yoga in type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
25.00 Year(s) 至 75.00 Year(s)(—)

入选标准

  • Known / diagnosed Type-2 diabetics picked up from screened population with >60 score on IDRS Gender: Both male and female Age: 25-75 years Without hypertension and obesity Those on oral hypo glycemic drugs; Metformin & Glimepiride only 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 Unable to perform Yoga.

结局指标

主要结局

Pro insulin

时间窗: Baseline and End of Study (After 3 months)

Insulin

时间窗: Baseline and End of Study (After 3 months)

C peptide

时间窗: Baseline and End of Study (After 3 months)

Fasting blood glucose

时间窗: Baseline and End of Study (After 3 months)

HbA1C

时间窗: Baseline and End of Study (After 3 months)

次要结局

  • Lipid Profile(Liver Function tests)

研究者

发起方
Jivanti Welfare and Charitable Trust
申办方类型
Other [Welfare and Charitable Trust]

研究点 (1)

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