| CTRI Number |
CTRI/2024/07/070069 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of tobacco use by rural women in wardha |
|
Scientific Title of Study
|
A cross-sectional study of Smokeless Tobacco Use among Women in Rural Wardha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Manoj Kaple |
| Designation |
Postgraduate student |
| Affiliation |
Data Meghe Institute of Heigher Education and Research |
| Address |
Department of community medicine ,3 rd floor SEPH, Jawaharlal Nehru Medical College, DMIHER Campus ,Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
7709765832 |
| Fax |
|
| Email |
skaple305@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashok Mehendale |
| Designation |
Professor Community Medicine Department |
| Affiliation |
Data Meghe Institute of Heigher Education and Researc |
| Address |
Department of community medicine ,3 rd floor Jawaharlal Nehru Medical College, DMIHER Campus ,Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9822253315 |
| Fax |
|
| Email |
ashokmehendale22@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashok Mehendale |
| Designation |
Professor Community Medicine Department |
| Affiliation |
Data Meghe Institute of Heigher Education and Researc |
| Address |
Department of community medicine ,3 rd floor Jawaharlal Nehru Medical College, DMIHER Campus ,Wardha
MAHARASHTRA 442001 India |
| Phone |
9822253315 |
| Fax |
|
| Email |
ashokmehendale22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Data Meghe Institute of Heigher Education and Research Sawangi. Meghe, Wardha,Maharashtra, 442001 |
|
|
Primary Sponsor
|
| Name |
Data Meghe Institute of Heigher Education and Research |
| Address |
Sawangi, Wardha |
| 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 |
| Shraddha Kaple |
Jawaharlal Nehru medical College |
Department of Community Medicine ,3rd floor SEPH, Jawaharlal Nehru Medical college,DMIHER, Sawangi, Wardha Wardha MAHARASHTRA |
7709765832
skaple305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Data Meghe Institute of Heigher Education and Reserach |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevalence and Pattern Of Smokeless Tobacco in women Rural Wardha |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 15 to 49 years. And women who will be willing to participate in the study after giving informed consent |
|
| ExclusionCriteria |
| Details |
Those women have Oral cancer, Lung Cancer, Throat cancer, and COPD. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcomes include determining prevalence rates, identifying usage patterns, exploring the frequency of consumption, and assessing socio-cultural factors influencing tobacco use in this specific demographic. |
Assessment will be done in 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
16/07/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Smokeless
tobacco use is a public health concern with significant implications for
Women’s well-being, especially in rural areas. Smokeless tobacco products can
be consumed through chewing, oral or nasal snuffing, rubbing on teeth and gums,
gargling, or ingestion. Smokeless tobacco globally causes over 8 million deaths
yearly, including 1.3 million non-smokers. Smokeless tobacco use by rural
Indian women harms both their health and family well-being. In Wardha, the
NFHS 5 survey (2019-2020) indicates that 9.5% of women aged 15 and
above use tobacco. The present
study will be a community-based cross-sectional. It will be conducted in all
villages under the rural field practice area of the Department of Community
Medicine, JNMC, Sawangi (M), Wardha in women aged between 15-49 years in rural
areas of Wardha district. The present study duration will be 2024-2025. The
study will collect data using systematic random sampling and a structured
questionnaire through interviews and observations. The examination of smokeless tobacco use among
women in rural Wardha carries significant implications for public health.
smokeless tobacco use can have various implications for health. Smokeless
tobacco elevates the risk of oral cancer, gum disease, and other oral health
issues, while also carrying social and cultural implications
in the community. |