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Clinical Trials/CTRI/2019/02/017500
CTRI/2019/02/017500CompletedNot Applicable

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 site in 1 country120 target enrollmentStarted: February 14, 2019Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Pro insulin

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
25.00 Year(s) to 75.00 Year(s) (—)

Inclusion Criteria

  • 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%.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pro insulin

Time Frame: Baseline and End of Study (After 3 months)

Insulin

Time Frame: Baseline and End of Study (After 3 months)

C peptide

Time Frame: Baseline and End of Study (After 3 months)

Fasting blood glucose

Time Frame: Baseline and End of Study (After 3 months)

HbA1C

Time Frame: Baseline and End of Study (After 3 months)

Secondary Outcomes

  • Lipid Profile(Liver Function tests)

Investigators

Sponsor
Jivanti Welfare and Charitable Trust
Sponsor Class
Other [Welfare and Charitable Trust]

Study Sites (1)

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