| CTRI Number |
CTRI/2013/12/004217 [Registered on: 16/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pilot testing of yoga programme for patients with type 2 diabetes mellitus |
|
Scientific Title of Study
|
Feasibility and pilot testing of yoga programme for patients with type 2 diabetes mellitus |
| Trial Acronym |
FPYD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Jagannathan |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)- Institute |
| Address |
Division of Yoga and Life Sciences, # 19, Eknath Bhavan, Gavipuram Circle,Kempe Gowda Nagar, Bengaluru
Bangalore
KARNATAKA
560019
India |
| Phone |
9448150690 |
| Fax |
|
| Email |
jaganaarti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Thulasi |
| Designation |
Research Scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)- Institute |
| Address |
No.19, Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bangalore
Bangalore
KARNATAKA
560019
India |
| Phone |
8867568042 |
| Fax |
|
| Email |
arunthulli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Thulasi |
| Designation |
Research Scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)- Institute |
| Address |
No.19, Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bangalore
Bangalore
KARNATAKA
560019
India |
| Phone |
8867568042 |
| Fax |
|
| Email |
arunthulli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekananda Yoga Anusandhana Samsthana SVYASA |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana SVYASA |
| Address |
No. 19, Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bangalore
Pin- 560 019 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Arun Thulasi |
Swami Vivekananda Yoga Anusnadhana Samsthana (SVYASA) |
Division of Yoga and Life Sciences, # 19, Eknath Bhavan, Gavipuram Circle,Kempe Gowda Nagar, Bengaluru
Bangalore
KARNATAKA |
8867568042
arunthulli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVYASA Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Nil |
| Intervention |
Yoga |
1 hour daily for 10 days (as part of a yoga camp for the patients suffering from Type 2 Diabetes in the local community. This would be conducted in two independent camps for 10 days in the community.The proposed yoga module would be taught by local community people who will be trained by the researcher a month prior to the camps.The performance of the trainers in teaching the patients during the camps would also be assessed using the observation checklist. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Languages understood: English, Hindi, Tamil, Telugu, Kannada
2. Patients willing to undergo yoga for the study. |
|
| ExclusionCriteria |
| Details |
Patients who are practicing regularly yoga for last 3 months yoga. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FBS |
Assessed at Baseline (Day 0), post intervention
(Day 10) from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility interview schedule |
Assessed at Baseline (Day 0), post intervention
(Day 10) from baseline |
| PPBS |
Assessed at Baseline (Day 0), post intervention
(Day 10) from baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Thulasi A, Kumar V, Jagannathan A, Angadi P, Umamaheshwar (2014). Development, validation and feasibility testing of yoga programme for patients with type 2 diabetes mellitus. BMC Complementary and Alternative Medicine. [Under Review]. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Feasibility testing of any yoga module is important as only if the practices are found to be feasible by the target sample, the effectiveness of the module can be tested. In this context, the aim of this study was to assess the feasibility and pilot test a newly developed yoga module for Type 2 Diabetes. A pre-post experimental research design was employed in two 10 day camp(s) at VASK yoga centre using purposive sampling. Total of 52 participants were enrolled for the study after screening. The yoga module basically comprised of prayers, loosening practices, Surya Namaskara, Asanas, Pranayama, Relaxation techniques, OM meditation and lectures on various relevant topics on diabetes and yoga. Assessments such as FBS, PPBS, and other clinical parameters as well as qualitative assessments including patient and trainer interviews, observation of the yoga session was conducted pre and post the camp. |