| CTRI Number |
CTRI/2022/09/045677 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| 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
|
Effect of yoga on obesity |
|
Scientific Title of Study
|
Effect of Suryanamaskara and Heating Pranayama on Grade 1 Obesity- A Randomised Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khundrakpam Geetarani Devi |
| Designation |
MD Scholar |
| Affiliation |
Alvas College of Naturopathy and Yogic sciences |
| Address |
Yoga department,Room no- 07 Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8073756664 |
| Fax |
|
| Email |
geetaranikhundrakpam99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrinda bedekar |
| Designation |
HOD (Clinical Yoga) |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Room no-07, Yoga department, Alvas college of naturopathy and yogic sciences, mijar, moodbidri,
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9008959711 |
| Fax |
|
| Email |
vrindabedekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathi K V |
| Designation |
Assistant Professor, Co-Guide |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Room no-07, Yoga department, Alvas college of naturopathy and yogic sciences, mijar, moodbidri,
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9964743920 |
| Fax |
|
| Email |
drswathi806@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of Naturopathy and Yogic sciences, Mijar, moodbidiri |
|
|
Primary Sponsor
|
| Name |
Dr Khundrakpam Geetarani Devi |
| Address |
Alvas college of naturopathy and yogic sciences, Mijar, Moodbidri, Dakshina Kannada dakshina kannada |
| Type of Sponsor |
Other [Self sponser] |
|
|
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 Khundrakpam Geetarani Devi |
Alvas college of Naturopathy and Yogic sciences |
Room no- 07, Yoga Department, Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA |
8073756664
geetaranikhundrakpam99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Studies of Alvas College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Intervention |
Duration:
Follow up for 4 weeks. |
| Intervention |
Yoga: Suryanamaskara and Heating pranayama |
Duration:
45 minutes per day for 5 days in a week for the duration of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group-between 18-30years are selected for the study.
2. Gender-Both male and female
3. Subjects with grade 1 obesity. |
|
| ExclusionCriteria |
| Details |
1. Co morbidity associated with obesity.
2. Subject taking other treatments.
3. Alcohol consumption.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Body weight measurement
2. Waist circumference measurement.
3. Skin folds thickness measurement. |
Assesments done at two time points:
Pre- assessment- Day 0- before intervention start
Post- assessment- Day 30- After intervention of 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Height Measurement |
Assesments done at two time points:
Pre- assessment- Day 0- before intervention start
Post- assessment- Day 30- After intervention of 4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2023 |
| Date of Study Completion (India) |
29/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/08/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity is the condition of
excessive accumulation of fat and fat depots resulting in more than 20% of the
excess expected body weight.1In India individuals affected by
obesity are more than 135 million and the prevalence of obesity is more acute
in women than males.
- Yoga is
an art, a science, and a philosophy. It touches the life of man at every level,
physical, mental and spiritual. It is a practical method for making one’s life
purposeful, useful, and noble.
- the practice of
Suryanamaskara gives a great number of benefits. It strengthens the back and
helps balance the metabolism
- Kapalabhati
pranayama, Bhastrika pranayama and Surya anulomaviloma means
“heating and generating breathing structures.
- This study is planned to study the effectiveness of Suryanamaskara
And Heating Pranayama On Grade 1 Obesity. |