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CTRI Number  CTRI/2019/02/017500 [Registered on: 06/02/2019] Trial Registered Prospectively
Last Modified On: 21/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Management of Type 2 Diabetes through Yoga and Ayurveda 
Scientific Title of Study   A Randomised control trial for the mechanism of action of Yoga and Ayurveda with Yoga in Type-2 Diabetes mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nagaratna R 
Designation  Medical Director 
Affiliation  Vivekananda Yoga Anusandhana Samsthana 
Address  VYASA, Arogyadhama hospital, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru

Bangalore Rural
KARNATAKA
560105
India 
Phone  08022639953  
Fax    
Email  rnagaratna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagaratna R 
Designation  Medical Director 
Affiliation  Vivekananda Yoga Anusandhana Samsthana 
Address  VYASA, Arogyadhama hospital, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru

Bangalore Rural
KARNATAKA
560105
India 
Phone  08022639953  
Fax    
Email  rnagaratna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Singh 
Designation  Resident Medical Officer 
Affiliation  Vivekananda Yoga Anusandhana Samsthana 
Address  VYASA, Arogyadhama hospital, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru

Bangalore Rural
KARNATAKA
560105
India 
Phone  08022639953  
Fax    
Email  dramits90@gmail.com  
 
Source of Monetary or Material Support  
Welfare and Charitable Trust. 8/3, Asaf Ali Road, New Delhi, 110002 
 
Primary Sponsor  
Name  Jivanti Welfare and Charitable Trust 
Address  8/3, Asaf Ali Road, New Delhi, 110002 
Type of Sponsor  Other [Welfare and Charitable Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jigisha M Mehta  Arogyadhama  VYASA, Arogyadhama hospital, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Bangalore Rural
KARNATAKA 
8928519959

jigme4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SVYASA, Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AYUSH-82 extract tablet  4 tablets per day (2 in the morning, 2 at night), for a period of 6 months  
Comparator Agent  Control Group  Participants will continue with regular routine 
Intervention  Yoga  Standardized Yoga Module for Type-2 Diabetes Mellitus practised for 3 months 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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%
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fasting blood glucose
HbA1C
Pro insulin
Insulin
C peptide
 
Baseline and End of Study (After 3 months) 
 
Secondary Outcome  
Outcome  TimePoints 
Lipid Profile
Liver Function tests
Kidney function tests
Glucagon
Somatostatin
Pancreatic polypeptide
GLP1 and GIP
Acetylcholine
Malonyl CoA
Free Fatty Acid Analysis
Leptin
Adiponectin


 
Baseline and End of Study (After 3 months) 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2019 
Date of Study Completion (India) 18/01/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

1.              INTRODUCTION

Diabetes has been on the rise in India. There is now more than ever, a need to have a comprehensive cost-effective mass health care strategy to address the disease and its associated complication. Apart from the management of Diabetes, it also becomes vital to screen and identify the high-risk population and put in place appropriate interventions / strategies to prevent progression to diabetes mellitus.

S-VYASA (a deemed University under section 3 of UGC act 1956), is a NAAC A+ accredited University established in 2002 with a vision to make Yoga a socially relevant science. As a part of our mission, we have scientifically validated Yoga practices and have been able to scientifically develop and administer personalised disease specific Yoga modules. In 2016, our initiative ’Stop Diabetes Movement’ was adopted by the Ministry Of AYUSH as a national program – Niyantritha Madhumeha Bharatha [NMB] – an initiative to treat and prevent incidence of Diabetes mellitus

.

Under the national scheme NMB, we have screened 2,40,968 adults for Diabetes Mellitus across the country. Under the same scheme diagnosed diabetic and high-risk individuals were treated with Yoga and were followed up for 3 months to understand the efficacy of Yoga, to treat diabetes and to prevent conversion of pre-diabetics to diabetics.  In continuation, we here propose to study efficacy and mechanism of action of Ayurveda and Yoga in prevention & management of Diabetes through Ayurveda & Yoga. Standardized ayurvedic formulation, Ayush-82 and Integrated Approach of Yoga Therapy (IAYT) module used previously in SDM will be used as interventions. The study is funded under the CSR program of Jivanti Welfare and Charitable 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.


 
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