| CTRI Number |
CTRI/2019/12/022306 [Registered on: 11/12/2019] Trial Registered Prospectively |
| Last Modified On: |
08/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Prevalence study on the use of smokeless tobacco among adult population in an urban resettlement colony of Delhi |
|
Scientific Title of Study
|
Epidemiological study on the use of smokeless tobacco among adult population in an urban resettlement colony of Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varun singh |
| Designation |
Post graduate resident |
| Affiliation |
Maulana azad medical college |
| Address |
Department of community medicine,3rd Floor, Pathology Block,Maulana azad Medical college,New delhi-110002
Central
DELHI
110002
India |
| Phone |
9821491230 |
| Fax |
|
| Email |
varunn1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M M Singh |
| Designation |
Director proffessor |
| Affiliation |
maulana azad medical college |
| Address |
Department of community medicine,3rd floor,pathology block,Maulana azad medical college- 110002
Central
DELHI
110002
India |
| Phone |
9968604248 |
| Fax |
|
| Email |
megharita1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M M Singh |
| Designation |
Director Proffessor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of community medicine,3rd floor,pathology block,maulana azad medical college,New delhi - 110002
Central
DELHI
110002
India |
| Phone |
9968604248 |
| Fax |
|
| Email |
megharita1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college,New Delhi,110002 |
|
|
Primary Sponsor
|
| Name |
Dr varun singh |
| Address |
Department of community medicine , maulana azad medical college - 110002 |
| Type of Sponsor |
Other [self] |
|
|
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 varun singh |
Maulana azad medical college |
Urban health centre,1st floor
gokulpuri-110094
Central
DELHI |
9821491230
varunn1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The Study subjects are asked about the smokeless tobacco use . |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
The study subjects must be a resident of the locality for at least for one year. |
|
| ExclusionCriteria |
| Details |
The study subjects must not be suffering from any
debilitating disease. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of smokeless tobacco use among adults in % along with 95% confidence interval. |
one year study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Awareness of study subjects ( in %) regarding harmful effects of tobacco use.
Awareness of study subjects regarding various aspects of COTPA. |
one year study period |
|
|
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)
|
12/12/2019 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
The study is an observational cross sectional study which aims to estimate the prevalence of smokeless tobacco use among adult population in an urban resettlement colony of Delhi. Study will be conducted for a period of 1 year in the Gokalpuri area located in the north east district of Delhi. Study subjects will be selected by systematic random sampling method and will be conducted by house-to-house visit to all houses. Study subject will be interviewed through the pre-structured questionnaire. the data will be calculated using an interview schedule , which will have questions divided into the following sections : 1. the socio-demographic and economic profile of the study subjects such as name , age , sex, occupation,literacy level, total income, total family members , per capita income. 2. the knowledge regarding the harmful effects of smokeless tobacco and provision of COTPA 3. factors associated with the initiation and continous use of smokeless tobacco . 4. Awareness on health effects of tobacco and COTPA .
|