| CTRI Number |
CTRI/2018/04/013169 [Registered on: 11/04/2018] Trial Registered Prospectively |
| Last Modified On: |
25/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Type 2 Diabetes and yoga intervention |
|
Scientific Title of Study
|
The Impact of Yoga intervention on physical and mental health of adults with Type 2 Diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPoongothai subramani |
| Designation |
Sr Scientist Head Clinical Trials |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.4, Conran Smith Road,
Gopalapuram, Chennai-600086
Chennai
TAMIL NADU
600086
India |
| Phone |
914443968888 |
| Fax |
914428350935 |
| Email |
poongothaisubramani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poongothai Subramani |
| Designation |
SR Scientist Head Clinical Trials |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.4, Conran Smith Road,
Gopalapuram, Chennai-600086
Chennai
TAMIL NADU
600086
India |
| Phone |
914443968888 |
| Fax |
914428350935 |
| Email |
poongothaisubramani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poongothai Subramani |
| Designation |
SR Scientist Head Clinical Trials |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.4, Conran Smith Road,
Gopalapuram, Chennai-600086
Chennai
TAMIL NADU
600086
India |
| Phone |
914443968888 |
| Fax |
914428350935 |
| Email |
poongothaisubramani@gmail.com |
|
|
Source of Monetary or Material Support
|
| MINISTRY OF AYUSH
AYUSH BHAWAN, B Block,
GPO Complex, INA, NEW DELHI - 110023 |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH Government of India |
| Address |
AYUSH BHAWAN, B-Block, GPO Complex, INA, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr S Poongothai |
Madras Diabetes Research Foundation |
Depart of clinical trials, Ustav flas 1st floor. 4 conran smith road gopalapuram chennai 600086
Chennai
TAMIL NADU |
9840134505
4428350935
poongothaisubramani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF MADRAS DIABETES RESEARCH FOUNDATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The intervention group will be encouraged to attend 30 minute yoga classes every 2 weeks, over a period of 12 weeks. After 12 weeks of intervention there will be follow-up period of 3 months (12 weeks) .During the follow-up period the participants will be asked to continue the yoga practice. There will be a telephone contact during these 3 months to assess the compliance. |
The intervention group will be encouraged to attend 30 minute yoga classes every 2 weeks, over a period of 12 weeks. After 12 weeks of intervention there will be follow-up period of 3 months (12 weeks) .During the follow-up period the participants will be asked to continue the yoga practice. There will be a telephone contact during these 3 months to assess the compliance. |
| Comparator Agent |
The intervention group will be encouraged to attend 30 minute yoga classes every 2 weeks, over a period of 12 weeks. After 12 weeks of intervention there will be follow-up period of 3 months (12 weeks) .During the follow-up period the participants will be asked to continue the yoga practice. There will be a telephone contact during these 3 months to assess the compliance. |
The intervention group will be encouraged to attend 30 minute yoga classes every 2 weeks, over a period of 12 weeks. After 12 weeks of intervention there will be follow-up period of 3 months (12 weeks) .During the follow-up period the participants will be asked to continue the yoga practice. There will be a telephone contact during these 3 months to assess the compliance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
HbA1c ≥ 7.0 to < 10.5 % |
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes mellitus
Patients with a serum creatinine concentration greater than 132.6 mmol/L (1.5 mg/dL) or liver function impairment (AST and ALT 2.5 times upper limit of normal range)
Patients have laboratory test abnormality (biochemistry, hematology, or urinalysis)
Patients with significant alcohol, drug or medication abuse
Currently under a psychiatrist’s care or using antipsychotic or mood stabilizer medication or have diagnosed dementia or bipolar disorder or schizophrenia;
Pregnant or lactating
Had a documented CVD event (MI, stroke) in past 12 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of yoga intervention in reduction of HbA1c levels. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of yoga intervention on mental health parameters
To assess the effect of yoga intervention on blood pressure and lipid profile
|
3 Months |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "152"
Final Enrollment numbers achieved (India)="152" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2018 |
| Date of Study Completion (India) |
09/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Though there are studies which have looked at the impact of yoga
intervention on depressive symptoms, stress, cognitive impairment, mindfulness
and quality of life separately, there is no study in India which has looked at
the comprehensive assessment of mental health and the impact of yoga on type 2
diabetes.
We will assess the impact of yoga-pranayama on depression, stress,
cognition and various metabolic parameters such as glycemic control,
hypertension, and dyslipidemia amongst participants with type 2diabetes in a
hospital environment, using subjective and objective measures. |