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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  
Name  Address 
NIL  NA 
 
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  
Status 
Not Applicable 
 
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 tobaccoThe 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.

 
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