| CTRI Number |
CTRI/2015/01/005433 [Registered on: 20/01/2015] Trial Registered Prospectively |
| Last Modified On: |
08/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized control trial to find out the effect of Integrated Approach of Yoga Therapy on Overweight and Obesity for Males |
|
Scientific Title of Study
|
The Effect of Integrated Approach of Yoga Therapy on Overweight and Obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Choudhary Ram |
| Designation |
Asst. Professor |
| Affiliation |
SVYASA YOGA University |
| Address |
Dr Nidhi (Choudhary) Ram
Asst Prof
Swami Vivekananda Yoga Anusandhana Samsthana(SVYASA YOGA UNIVERSITY)
Eknath Bhavan
No. 19, Gavipuram Circle
Kempegowdanagar
Bangalore-560 019
svyasa.org
Bangalore
KARNATAKA
560 019
India |
| Phone |
|
| Fax |
|
| Email |
nidhiyoga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P B Rshikesan |
| Designation |
PhD Student |
| Affiliation |
SVYASA YOGA University |
| Address |
SVYASA YOGA UNIVERSITY 19 Ekanath Bhavan,Gavipuram Circle,KG Nagar
Bangalore
Bangalore
KARNATAKA
560019
India |
| Phone |
|
| Fax |
|
| Email |
hrishipb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P B Rshikesan |
| Designation |
PhD Student |
| Affiliation |
SVYASA YOGA University |
| Address |
10 B Udayagiri,Anushaktinagar
Mumbai
Mumbai
MAHARASHTRA
400094
India |
| Phone |
|
| Fax |
|
| Email |
hrishipb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
P B Rshikesan |
| Address |
Research scholar Swami Vivekananda Yoga Anusandhana Samsthana(SVYASA YOGA UNIVERSITY)
Eknath Bhavan
No 19 Gavipuram Circle
Kempegowdanagar
Bangalore-560 019 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| P B Rshikesan |
Brindavan Yoga Hall |
Yoga Hall, Brindavan Building, Ground Floor
Anushaktinagar,
Mumbai 400094
Mumbai
MAHARASHTRA |
09969666897
hrishipb@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OF SVYASA YOGA UNIVERSITY BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity/Over weight |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IAYT YOGA MODULE |
Asana,Pranayama,Relaxation,Meditation covering all the 5 layers of consiouness(Pancha kosa)This will be done for one and half hour per day for 5 days ina week for 6 months |
| Comparator Agent |
Walking |
Walking will be continued half an hour to one hour for 5 days in a week for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Normally healthy persons except over weight/obesity
Capability to perform simple yoga practices
General Health score >3 |
|
| ExclusionCriteria |
| Details |
Women
Physically handicapped
Cannot read write English
Surgeries& medically restricted conditions
Regular yoga practitioners |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Obesity/Over weight parameters
Body composition
Psychological questionnaires such as
Perceived stress scale (PSS)
|
Assessment of Obesity/Over weight parameters
Body composition
Psychological questionnaires such as
Perceived stress scale (PSS)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diet log
Exercise log |
6 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2015 |
| Date of Study Completion (India) |
20/09/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Advertisements/Camp & other public communications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised control trial(with minimisation for co factors) to investigate the effects of 24 weeks of integrated approach of yoga therapy (IAYT) program on anthropometric, clinical and psychological profile of obese/overweight Indian adult male.
The hypothesis is the changes in clinical, anthropometric and psychological measures brought about by IAYT would differ from the changes in the control group of obese male individuals. The 3 types of parameters of the control group and yoga group will be measured at 0 date, 3 months and at 6 months for both yoga and control groups.
Yoga group will do a specific (IAYT) yoga module for 1 and half hours per day, for 5 days in a week for 3 months with supervision.After 3 months next 3 months yoga group will do same yoga module without supervision at their home. The control group will continue to do the exercises/walking etc which they have been doing at the time of recruitment,for all these 6 months.
Both groups will also maintain a diet and exercise log for 6 months.
|