CTRI Number |
CTRI/2024/03/063976 [Registered on: 11/03/2024] Trial Registered Prospectively |
Last Modified On: |
08/03/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effect of sun salutations on increased body weight |
Scientific Title of Study
|
A comparative study of dynamic and static surya namaskara on physiological variables among obese individuals: a randomized controlled trial |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shashi Prabha Pandey |
Designation |
PG Scholar |
Affiliation |
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire. |
Address |
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Department of yoga, first floor, siddhavana, college road, Ujire.
Dakshina Kannada KARNATAKA 574240 India |
Phone |
9901105963 |
Fax |
|
Email |
shashiprabhap115@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shashi Prabha Pandey |
Designation |
PG Scholar |
Affiliation |
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire. |
Address |
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Department of Yoga, first floor, Siddhavana, college road, Ujire.
Dakshina Kannada KARNATAKA 574240 India |
Phone |
9901105963 |
Fax |
|
Email |
shashiprabhap115@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ganesh Prasad |
Designation |
Medical Officer |
Affiliation |
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire. |
Address |
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Department of Yoga, first floor, Siddhavana, college road, Ujire.
Dakshina Kannada KARNATAKA 574240 India |
Phone |
9632608127 |
Fax |
|
Email |
gpbnys@gmail.com |
|
Source of Monetary or Material Support
|
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Yoga Department, first floor, college road, Ujire. 574240 Taluk: Belthangady. District: Dakshin Kannada |
|
Primary Sponsor
|
Name |
Shri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital |
Address |
Shri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Dharmasthala |
Type of Sponsor |
Private hospital/clinic |
|
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 Shashi Prabha Pandey |
Shri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Dharmasthala. |
Centre of Excellence building, Ground Floor, Bio-physical Laboratory, Dharmasthala. 574240 Taluk: Belthangady. Dakshina Kannada KARNATAKA |
9901105963
shashiprabhap115@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SDM Institutional Ethical Committee |
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 |
Dynamic surya namaskara |
Static surya namaskara protocol including loosening practices Toe bending, Ankle bending, Ankle rotation, Half butterfly, Hand Clenching, Wrist bending, Wrist joint rotation, Elbow bending, Shoulder rotation, Neck movements and Knee bending 5 rounds each side. Followed by 3 rounds of dynamic Suryanamaskara without holding followed by 10 minutes of Deep relaxation technique. |
Intervention |
Static surya namaskara protocol |
Static surya namaskara protocol including loosening practices Toe bending, Ankle bending, Ankle rotation, Half butterfly, Hand Clenching, Wrist bending, Wrist joint rotation, Elbow bending, Shoulder rotation, Neck movements and Knee bending 5 rounds each side. Followed by 3 rounds of Suryanamaskara in which each posture will be maintained for the duration of 1 to 3 minutes followed by 10 minutes of Deep relaxation technique. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
Subjects diagnosed as overweight and obese according to Asian classification.
Obese and overweight individuals without any co-morbidity.
Individuals with no prior yoga experience.
|
|
ExclusionCriteria |
Details |
Individuals with yoga experience.
Obese and overweight individuals with co-morbidities.
Subjects with morbid obesity.
Patients with recent surgeries, neuromuscular, orthopedic or patients who were advised to refrain from any form of exercise.
Obese individuals with autoimmune or established CAD or any organic vascular disease, history of neurological / thyroid disorders, nutritional disorders and any other acute illness.
Pregnant and lactating women.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Lipid Profile
Clinical Anthropometry - Height, Weight, Body Mass Index, Waist-Hip ratio
Body Adiposity Index
Corpulence Index
Body Composition Analysis - Bone mass, body water, BMR, Body fat mass, Fat free mass, Visceral Fat, Skeletal Muscle |
Lipid Profile
Clinical Anthropometry - Height, Weight, Body Mass Index, Waist-Hip ratio
Body Adiposity Index
Corpulence Index
Body Composition Analysis - Bone mass, body water, BMR, Body fat mass, Fat free mass, Visceral Fat, Skeletal Muscle
on Day 1 and Day 31 |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
20/03/2024 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="24" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Obesity is the excessive or abnormal accumulation of fat or
adipose tissue in the body that impairs health via its association to the risk
of development of diabetes mellitus, cardiovascular disease, hypertension, and
hyperlipidemia. Current treatments available for obesity includes
various diets such as meal replacement, calorie restriction, mediterranean diet
etc. which are effective when combined with good physical exercise regime. Pharmacotherapy
includes drugs such as orlistat, liraglutide (appetite suppression), naltrexone
(appetite suppression) etc. which are effective but are not devoid of side
effects and their long term effects on the health are unknown. Physical activity
and/or exercise are commonly included as components of lifestyle interventions
for weight loss. There are no specific recommendation mentioned on type and
intensity of exercise. Various studies using aerobic, resistance or combination
of both types of exercises have shown to have health benefits. It is need of
the moment to develop an effective regime for prevention as well as management
of obesity and obesity related co morbidities. Suryanamaskara is physical yogic
practice which involves sequential combination of yogic postures performed
dynamically in synchrony with the breath. Suryanamaskara has been found to be
effective in management of obesity among women. Usually, it is practiced in a
dynamic manner which is not convenient to people who have hypertension, low
strength, morbid obesity or any other musculoskeletal ailments. This study is
to find out whether static Suryanamaskara will be able to avail satisfactory
results. So, that it can be incorporated for the individuals for whom dyanamic
Suryanamskara is not convenient. This study was planned based on our
hypothesis that these two methods of Sun salutation based on different speeds
would have different effects on different parts of the body in individuals with
obesity and will avail similar results. |