| CTRI Number |
CTRI/2019/02/017750 [Registered on: 20/02/2019] Trial Registered Prospectively |
| Last Modified On: |
25/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized controlled trial to study the effects of one year Yoga intervention in patients with Type 2 Diabetes |
|
Scientific Title of Study
|
Yoga Based Lifestyle Intervention for Type 2 Diabetes: A Randomized Controlled Study with One Year Follow up using Thermal Imaging and Electro-photonic Imaging |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Suman Bista |
| Designation |
PhD Scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA University) |
| Address |
Prashanti Kutiram, Vivekananda Road, Kallubalu Post, Jigani Hobli, Anekal Taluk, Bengaluru – 560105
Bangalore
KARNATAKA
560105
India |
| Phone |
09901053538 |
| Fax |
08026608645 |
| Email |
suman.bista002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Senior Scientific Officer |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
NIMHANS Integrated Centre for Yoga (NICY), Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore – 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995730 |
| Fax |
08026995983 |
| Email |
hemant.bhargav1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Senior Scientific Officer |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
NIMHANS Integrated Centre for Yoga (NICY), Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore – 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995730 |
| Fax |
08026995983 |
| Email |
hemant.bhargav1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology (DST) - Science and Engineering Research Board (SERB), 5 & 5A, Lower Ground Floor, Vasant Square Mall, Sector-B, Pocket-5, Vasant Kunj, New Delhi – 110070 |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana SVYASA University |
| Address |
Prashanti Kutiram, Vivekananda Road, Kallubalu Post, Jigani Hobli, Anekal Taluk, Bengaluru – 560105 |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Prahlada Ramarao |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA University), Prashanti Kutiram, Vivekananda Road, Kallubalu Post, Jigani Hobli, Anekal Taluk, Bengaluru – 560105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemant Bhargav |
Govind’s Medical and Diabetes Centre |
Division of diabetes, Ground floor, House number; 541, 16th cross, 17th Main, 4th Sector, HSR Layout, Near BDA Complex, Bangalore - 560102
Bangalore
KARNATAKA |
08026995730
08026995983
hemant.bhargav1@gmail.com |
| Dr Hemant Bhargav |
Samatvam Endocrinology Diabetes Center |
Hall number; 1, House number; 313, Satyameva Jayathe, 17th Main, 4th T Block East, Jayanagar, Bangalore - 560011
Bangalore
KARNATAKA |
08026995730
08026995983
hemant.bhargav1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SVYASA |
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 |
| Comparator Agent |
physical exercise |
physical exercise (brisk walk for 45 minutes followed by 15 minutes rest per day, 5 days a week + Health education, once a week for initial 4 weeks) for one year |
| Intervention |
Yoga based lifestyle |
Yoga based lifestyle (Yoga module for T2DM developed by Ministry of AYUSH, Government of India, 1 hour per day/ 5 days a week + Counseling on yoga based lifestyle, once a week for initial 4 weeks) for one year |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with the diagnosis of type 2 diabetes
Subjects suffering from T2DM for maximum of 10 years
Either with or without medications
Subjects the MMSE (Mini Mental Status Examination) score above 24
Those willing to participate in the study
Those who can write, read and understand the English
|
|
| ExclusionCriteria |
| Details |
Those with uncontrolled T2DM
Those with Chronic Kidney disease
Those with Visual difficulties or k/c/o diabetic retinopathy
Those with established coronary artery disease or past history of heart disease
Those with h/o stroke or other major neurological disorders
Subjects with other metabolic disorders like hypothyroidism or hyperthyroidism
Those with severe psychiatric disorders
Those with h/o practicing Yoga regularly (at least once a week for one month or more) in the last 1 year
If the control group also follows some form of Yoga on regular basis during the period of study (at least once a week for one month or more), then they will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of 1 year Yoga based lifestyle intervention on HbA1c level of T2DM patients |
at baseline after 6 months and after 1 year of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of 1 year Yoga based lifestyle intervention on clinical symptoms of T2DM patients |
at baseline after 6 months and after 1 year of intervention |
| To assess the effect of 1 year Yoga based lifestyle intervention on other biochemical levels (FBS, PPBS) of T2DM patients |
at baseline after 6 months and after 1 year of intervention |
| To assess the effect of 1 year Yoga based lifestyle intervention on Electro-photonic Imaging parameters of T2DM patients |
at baseline after 6 months and after 1 year of intervention |
| To assess the effect of 1 year Yoga based lifestyle intervention on Thermal Imaging parameters of T2DM patients |
at baseline after 6 months and after 1 year of intervention |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= "176"
Final Enrollment numbers achieved (India)="176" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2019 |
| Date of Study Completion (India) |
16/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Muniscripts under preparation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is Randomized, parallel group, active controlled trial comparing the effects of Yoga based lifestyle (Yoga module for T2DM developed by Ministry of AYUSH, Government of India, 1 hour per day/ 5 days a week + Counseling on yoga based lifestyle, once a week for initial 4 weeks) and physical exercise (brisk walk for 45 minutes followed by 15 minutes rest per day, 5 days a week + Health education, once a week for initial 4 weeks) for one year in 176 patients with type 2 diabetes mellitus. The study will be conducted in Bangalore, India. The primary outcome of the study will be HbA1c level. The secondary outcomes will be other biochemical levels (FBS, PPBS), clinical symptoms, Electro-photonic Imaging parameters, and Thermal Imaging parameters.
|