| CTRI Number |
CTRI/2019/09/021162 [Registered on: 11/09/2019] Trial Registered Prospectively |
| Last Modified On: |
06/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out the dominance of lifestyle factor in obesity. |
|
Scientific Title of Study
|
A cross sectional study to evaluate the dominance of lifestyle factor in Sthaulya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshika Gupta |
| Designation |
P.G. Scholar, Department of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Sansthan, Khera dabar, Najafgarh.
South West
DELHI
110073
India |
| Phone |
08800868167 |
| Fax |
|
| Email |
anshi.gupta18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
HOD, Dept. Of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Sansthan, Khera dabar Najafgarh
South West
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
Shreemahalaxmi1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
HOD, Dept. Of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Ch Brahm Prakash Ayurved Sansthan |
| Address |
Ch Brahm Prakash Ayurved Sansthan, Khera dabar Najafgarh
South West
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
Shreemahalaxmi1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan khera dabar Najafgarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anshika Gupta |
Ch Brahm Prakash Ayurved Charak Sansthan |
Ch Brahm Prakash Ayurved Sansthan, Khera Dabar, Najafgarh
South West
DELHI |
08800868167
anshi.gupta18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with BMI more than 25 are included in study. |
|
| ExclusionCriteria |
| Details |
Morbid obesity associated with any severe illness
Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Obesity is a life style dominant disease. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation of obesity with lipid profile , thyroid function test, and blood sugar. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/09/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Article will be published in a reputed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sthaulya is excessive and abnormal accumulation of meda dhatu. In modern medical sciences it can be correlated to obesity. The BMI gives an indication of the state of obesity. The present proposed study will be an attempt to identify main lifestyle related aharatmak, viharatmak and mansika factor associated with sthaulya. |