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CTRI Number  CTRI/2023/03/051057 [Registered on: 27/03/2023] Trial Registered Prospectively
Last Modified On: 24/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy
Other (Specify) [suryanamaskara]  
Study Design  Other 
Public Title of Study   To observe the effect of practicing Suryanamaskar on people having obesity 
Scientific Title of Study   Effect of Suryanamaskar on sthaulya (obesity) w.r.t Body adiposity index- a prospective study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhilasha Bhardwaj 
Designation  PG Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room No. 312,Rachna Sharir Department, Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabur,Najafagarh

South West
DELHI
110073
India 
Phone  7042167939  
Fax    
Email  abhilashabhardwaj50@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh Kumar Sharma 
Designation  Associate professor 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room no.324 3rd floor Ch. brahm Prakash Ayurved Charak Sansthan ,Khera Dabur Najafgarh Delhi

South West
DELHI
110073
India 
Phone  9718505430  
Fax    
Email  drsharmamukesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh Kumar Sharma 
Designation  Associate professor 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room no.324 3rd floor CBPACS Khera Dabur Najafgarh Delhi

South West
DELHI
110073
India 
Phone  9718505430  
Fax    
Email  drsharmamukesh@gmail.com  
 
Source of Monetary or Material Support  
OPD/IPD OF CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
 
Primary Sponsor  
Name  CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  Khera Dabur Najafgarh New Delhi Pincode 110073 
Type of Sponsor  Government medical college 
 
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 
Abhilasha Bhardwaj  Chaudhary Brahm Prakash Ayurved Charak Sansthan  Room 316, 3rd Floor, Khera Dabur, Najafgarh
South West
DELHI 
7042167939

abhilashabhardwaj50@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CBPACS IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Surya Namaskara (Procedure Reference: Surya namaskar, Textbook of Yoga, Simple Yoga and Therapy, Yogeshwar, Madras 600 004 Ch 14, Page 22-24, Procedure details: We will give intervention of Surya Namaskar Therapy starting with Sukshma Vyayama followed by a series of physical postures with regulated breathing. It will be advised twice a day on empty stomach in the morning and evening starting from rounds 1,2,4,6,8,10,12 on Day 1,2,3,4,5,6,7 respectively. It will be performes slowly at own pace, pausing a little at the limit of each position. Each position should be held for five seconds before preceding to next.19 It is enough to perform Surya Namaskar )
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  • Waist to Hip Ratio
1) Waist to hip ratio
Women: >0.9
Men: >1.0
2)Study participants who don’t have any difficulty in body movements and are willing to practice Surya Namaskar on regular basis.
 
 
ExclusionCriteria 
Details  1)Subject with hypothyroidism, CVS Disease, Hemiplegia, HTN
2)A subject having WHR as follows:
Women: < 0.9, Men: < 1.0
3)Subject below the age of 20 and above the age of 50.
4)Subject with Joint Disorders.
5)Pregnant and Lactating Women

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The results of the study may indicate that by practicing Surya Namaskar there is a decrease in Body Adiposity Index in obese.  at baseline
after 1.5months
after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
The results of the study may indicate that by practicing Surya Namaskar there is a decrease in Body Adiposity Index in obese.  at baseline
after 4 weeks
after 8 weeks
after 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3 
Date of First Enrollment (India)   30/03/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION

Obesity is a state of excess adipose tissue mass. Obesity is associated with an increased risk of multiple health problems, including hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnoea, non-alcoholic fatty liver disease, degenerative joint disease, and some malignancies.1 Worldwide, more than 1 billion people are estimated to be overweight, and more than 300 million of these are considered obese, making Obesity one of the greatest threats to public health today. 2 In India, 1.3% of males and 2.5 % of females aged more than 20 years were obese in the year 2008.3 The Overall prevalence of overweight and obesity is expected to increase considerably in India by 2040, with substantial increases, particularly among rural residents and older Indians.

 


The concept of Sthaulya has been considered to be one among the Ashtaunindita Purusha.5 (eight undesirable conditions). Adiposity is a physiological characteristic of obese and overweight individuals, which increases the risk for cardiovascular disease.6

Nothing else than physical activity (Vyayama) exists which is best to reduce corpulence (Obesity)7. Surya Namaskar is practiced as it’s a full-body workout. Surya Namaskar not only stretches your body but also works on your cardiovascular system along with improving blood circulation. Doing one round of Surya Namaskar burns approximately 13.90 calories. Doing 12 sets of Surya Namaskar is equal to doing 288 yoga poses. Regular practice of Surya Namaskar provides your body with some exceptionally healthy benefits. It is a workout for your full body starting from the toe to your head.8

The Body Adiposity Index (BAI) is a practical anthropometric method used to measure body fat percentage (BF%)9. BAI, as an estimate of body fat percentage (BF%), is calculated using a simple equation that includes only hip circumference and body height. The rationale for this approach derives from a study by Bergman et al.10 The BMI has been used to assess body fat for almost 200 years. BMI is known to be of limited accuracy and is different for males and females with similar % body adiposity.11 BMI is a simple estimate of obesity based on the ratio of weight to height squared (weight (kg)/height squared (m2). However, a higher BMI does not always reflect increased body fat as excess weight can be due to increased muscle or bone mass, influenced by such factors as sex, age, genetics, exercise, and ethnicity. Recently, Body Adiposity Index (BAI) has been proposed as a new alternative to BMI. BAI is a nonlinear ratio of hip circumference to height (the hip circumference in cm/ [(height (m)1.5 -18]). Bergman et al. reported that BAI is strongly correlated with adiposity, and in contrast to BMI, BAI was equally good for both genders and differing ethnicities. BAI could directly estimate percent body fat without the need for further correction for sex or age.12*


 

RESEARCH QUESTION

Whether there will be any effect of Surya Namaskar on Sthaulya (Obesity) w.r.t. Body Adiposity Index?

 

NULL HYPOTHESIS

There is no significant effect of Surya Namaskar on Sthaulya (Obesity) w.r.t. Body Adiposity Index.

 

ALTERNATE HYPOTHESIS

 

There is a significant effect of Surya Namaskar on Sthaulya (Obesity) w.r.t. Body Adiposity Index.

 



 

AIM

To assess the effect of Surya Namaskar on Sthaulya (Obesity) w.r.t. Body Adiposity Index.

 

 

OBJECTIVES

1.     To measure the waist circumference of study participants

2.     To measure the hip circumference of study participants.

3.     To measure the height of study participants

4.     To calculate the BAI with the help of hip circumference and height by using formula BAI= Hip Circumference(cm)/ Height (m)1.5-18

 

MATERIALS AND METHODS

Study Centre:  Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi-110073

 

STUDY DESIGN-   Prospective Study

 

Duration of Study – 3 Months

 

Sample size- 100

The sample size formula by Fleiss is:-

P1 =    p2 OR/ 1+ p2 (OR-1)

 

OR =Odd’s Ratio

Prevalence of obesity = 11.8%

P1 (proportion of exposed with disease) = 109

P2 (proportion of the unexposed with diseases) =109

Total Sample Size =218

(218 is not feasible, therefore will take 100 subjects)

 

Study Material:

This study will recruit a population of 50 obese patients. Obesity is defined as the ratio of the circumference of the waist to the circumference of the hips (WHR= waist-to-hip-ratio )16, 0.9 in women and 1.0 in men. The waist circumference and Hip circumference of the subject will be measured according to Annexure 3 & Annexure 4 respectively.

 

METHODOLOGY-

 

Literary Study- The effect of Surya Namaskar on Body Adiposity Index in patients of Sthaulya (Obesity) will be studied from the reference books of Ayurveda & Modern science.

Ø  The enrolled subjects will be informed about the study through an information Sheet & written informed consent (Annexure 1) will be taken and their subject participation will be solicited.

Ø  After obtaining written consent from subjects, their Body Adiposity Index (BAI) will be calculated after measuring the hip circumference and height (Annexure 5) of study participants.

Ø  Surya Namaskar training (Annexure 6)17 will be given by the investigator in CBPACS Hospital. After that daily follow-up will be done either in the hospital or on zoom meeting regularly.

Ø  We will give intervention of Surya Namaskar Therapy starting with Sukshma Vyayama18 followed by a series of physical postures with regulated breathing. It will be advised twice a day on empty stomach in the morning and evening starting from rounds 1,2,4,6,8,10,12 on Day 1,2,3,4,5,6,7 respectively.

Ø  It is best to perform Surya Namaskar slowly at your own pace, pausing a little at the limit of each position. Each position should be held for five seconds before preceding to next.19 It is enough to perform Surya Namaskar for 10-15 minutes.

Ø  Body Adiposity Index will be assessed on Day 1 and after 30 days, 60 days, and 90 days of training according to Annexure 2.

 

Subjects of either gender will be taken in a single group and will be trained to perform Surya Namaskar.

 

EXPECTED OUTCOME

The results of the study may indicate that by practicing Surya Namaskar there is a decrease in Body Adiposity Index in obese.

 
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