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
|
|
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
|
|
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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