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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NA  NA 
 
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.

 
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