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CTRI Number  CTRI/2017/10/010094 [Registered on: 13/10/2017] Trial Registered Retrospectively
Last Modified On: 12/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A survey study on life style of obese persons in Ayurvedic perspective  
Scientific Title of Study   A cross sectional survey study to assess the lifestyle of obese in view of ayurvedic principles of healthy living 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Pant 
Designation  Second Year Pg Scholar 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan 
Address  Department Of Swasthavritta & Yoga Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9008397648  
Fax    
Email  anjalipant89@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivakumar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan 
Address  Department Of Swasthavritta & Yoga Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshiva.k@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivakumar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan 
Address  Department Of Swasthavritta & Yoga Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshiva.k@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan 
Address  BM Road Thanniruhalla Hassan Karnataka 573201 
Type of Sponsor  Private 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 
Dr Anjali Pant  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  Department of Swasthavritta and Yoga OPD 1
Hassan
KARNATAKA 
9008397648

anjalipant89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethicas Committe Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  OBESITY,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Adults aged between 18-60 years
2 Gender-both male and female
3 Those are ready to take part in study and give written consent
 
 
ExclusionCriteria 
Details  1 Obesity due to secondary causes
2 Severely ill patients
3 Subjects with Mental illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VALIDATED QUESTIONNAIRE ON AYURVEDIC PRINCIPLES OF HEALTHY LIVING   2 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
 
Target Sample Size   Total Sample Size="440"
Sample Size from India="440" 
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)   06/02/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Obesity develops when energy intake from food and drink consumption is greater than energy expenditure through the body’s metabolism and physical activity. A person’s own biological and psychological makeup, along with societal and environmental influences contribute to this complex process. Worldwide in 2014, more than 1.9 billion adults were overweight of which over 600 million were obese. It is mentioned and  well explained in Ayurveda that  how to lead a disciplined life by following and respecting the principles related to Ahara, Vihara, Achara and Vichara This study aims to assess the lifestyle of obese in view of ayurvedic principles of healthy living.

This is an observational study which will be done in two groups as a case-control study design. The subjects will be selected from those who visit the out patient and in patient department of Sri Dharmasthala Manjunatheswra College of Ayurveda and Hospital, Hasssan.   A previously validated questionnaire will be given to two groups of  440 subjects each, one non obese with 220 subjects and the other cases of obesity with 220 subjects. Their response will be tabulated and analyzed using proper statistical tests to come out with a valid conclusion about its relation to the disease.      

 
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