Management of Type 2 Diabetes through Yoga and Ayurveda

Completed

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/02/017500

Lead Sponsor: Jivanti Welfare and Charitable Trust

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 *â€™Stop Diabetes Movement*â€™ was adopted bythe Ministry Of AYUSH as a national program â€“ *Niyantritha Madhumeha Bharatha [NMB] â€“* 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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 â‰¥ 6.4%.

Exclusion Criteria

Morbid Obesity [BMI â‰¥ 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 â‰¥ 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pro insulin	Baseline and End of Study (After 3 months)
Insulin	Baseline and End of Study (After 3 months)
C peptide	Baseline and End of Study (After 3 months)
Fasting blood glucose	Baseline and End of Study (After 3 months)
HbA1C	Baseline and End of Study (After 3 months)

Secondary Outcome Measures

Name	Time	Method
Lipid Profile	Liver Function tests

Trial Locations

Locations (1): Arogyadhama
🇮🇳
Rural, KARNATAKA, India
Arogyadhama
🇮🇳Rural, KARNATAKA, India
Jigisha M Mehta
Principal investigator
8928519959
jigme4@gmail.com