| CTRI Number |
CTRI/2017/02/007874 [Registered on: 15/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
15/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of tobacco
|
|
Scientific Title of Study
|
Prevalence of tobacco consumption and its pattern among higher secondary school children in E ward, south mumbai- cross sectional study.
|
| Trial Acronym |
Prevalence, |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC782/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil Patil |
| Designation |
Student |
| Affiliation |
Department of Public Health |
| Address |
Department of Public Health,Manipal university, manipal
Department Of Public Health,Manipal University, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9916825466 |
| Fax |
0123 |
| Email |
drnikhilptl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhil Patil |
| Designation |
Student |
| Affiliation |
Department of Public Health |
| Address |
Department of Public Health,Manipal University, Manipal
Department of Public Health, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9916825466 |
| Fax |
0123 |
| Email |
drnikhilptl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Rane |
| Designation |
Program Co-Ordinator |
| Affiliation |
Aga khan health services |
| Address |
Aga khan health services Mumbai
Aga khan health services,Mumbai
Mumbai
MAHARASHTRA
400036
India |
| Phone |
9886271179 |
| Fax |
400036 |
| Email |
prasad.rane@pakh.net |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Nikhil Patil |
All Schools in Byculla E ward |
Mumbai E ward
Mumbai (Suburban)
MAHARASHTRA |
9916825466
0123
drnikhilptl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba hospital, manipal institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
8th to 10th stardard students |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
student |
|
| ExclusionCriteria |
| Details |
those who all are not willing to give the consent for study, and those who are absent on the day of survey. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
prevalence of tobacco consumption.
and its pattern of use
risk factors associated with tobacco consumption |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pattern of tobacco use among higher secondary school going children in south Mumbai |
6 months |
|
|
Target Sample Size
|
Total Sample Size="896"
Sample Size from India="896"
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)
|
09/02/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
This survey is basically for the estimation of prevalence of tobacco use and its pattern of consumption among higher secondary school going childrens in south mumbai. |