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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
OBESITY, |
|
Intervention / Comparator Agent
|
|
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
|
|
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. |