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CTRI Number  CTRI/2025/07/091423 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 20/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on How Warning Labels Help Adults Reduce Smoking 
Scientific Title of Study   EFFECTIVENESS OF WARNING LABELS ON CIGARETTE PACKETS OF DIFFERENT COUNTRIES IN ENHANCING SMOKERS MOTIVATION TO QUIT. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aruhi Sinha 
Designation  Post graduate student 
Affiliation  Government Dental College & Hospital Raipur, Chhattisgarh  
Address  Department of Public Health Dentistry, Room No. 13, Government Dental College, Raipur, C.G., 492001

Raipur
CHHATTISGARH
492001
India 
Phone  7033688832  
Fax  0771-2222990  
Email  aruhi.sinha1708@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramakrishna Chevvuri 
Designation  Associate Professor 
Affiliation  Government Dental College & Hospital Raipur, Chhattisgarh  
Address  Department of Public Health Dentistry, room no. 13, Government Dental College, Raipur, C.G., 492001


CHHATTISGARH
492001
India 
Phone  9826177279  
Fax  0771-2222990  
Email  drrkc15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aruhi Sinha 
Designation  Post graduate student 
Affiliation  Government Dental College & Hospital Raipur, Chhattisgarh  
Address  Department of Public Health Dentistry, room no. 13, Government Dental College, Raipur, C.G., 492001


CHHATTISGARH
492001
India 
Phone  7033688832  
Fax  0771-2222990  
Email  aruhi.sinha1708@gmail.com  
 
Source of Monetary or Material Support  
Primary Investigator, GDC Raipur, C.G., 492001 
 
Primary Sponsor  
Name  Dr Aruhi Sinha 
Address  Government Dental College, Raipur, C.G., 492001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aruhi Sinha  Government dental college, Raipur, Chhattisgarh  Department of Public Health Dentistry, room no. 13, Government Dental College, Raipur, C.G., 492001
Raipur
CHHATTISGARH 
7033688832
0771-2222990
aruhi.sinha1708@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals eligible for participation in this study must be aged 18 years or above and must consume smoking tobacco. Participants should have a history of smoking for at least one year and a daily consumption of a minimum of five cigarettes or an equivalent amount of smoking tobacco. Additionally, they must be able to read and understand either English or Hindi to ensure comprehension of study materials and questionnaires. Willingness to provide informed consent is also a prerequisite for inclusion in the study.  
 
ExclusionCriteria 
Details  individuals with systemic conditions will be excluded to minimize potential health-related confounding factors. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Awareness and alertness of tobacco consumers regarding smoking health risks influenced by cigarette warning labels across different country classifications.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of smokers reporting increased quitting intentions due to warning labels, assessed through a structured survey at baseline  baseline 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   31/07/2025 
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)  Open to Recruitment 
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  

Tobacco use remains a leading cause of preventable death and disease globally, with smoking responsible for over 8 million deaths annually. The World Health Organization (WHO) has introduced the Framework Convention on Tobacco Control (FCTC) guidelines, emphasizing health warnings on tobacco packaging to reduce consumption. These warnings include graphic images, textual messages, and standardized plain packaging to deter smoking. Implementation varies across 46 underdeveloped, 130 developing, and 66 developed countries, with factors such as policy strength, enforcement, and socio-economic conditions influencing their effectiveness. Developed nations like Canada and Australia have implemented comprehensive warning labels, leading to reduced smoking rates, while developing and underdeveloped countries face challenges such as weak enforcement and limited resources.

This cross-sectional study aims to compare the effectiveness of cigarette warning labels from 18 countries (6 each from developed, developing, and underdeveloped categories) in influencing smokers’ awareness, behavior, and motivation to quit. Conducted among tobacco-smoking patients at the OPD of Government Dental College and Hospital, Raipur, participants will be randomly selected and exposed to warning labels from different countries. Their responses will be assessed using the WHO tobacco warning labels and the GATS 2 questionnaire. The study will analyze the role of socio-economic factors in shaping the impact of these warnings and provide recommendations for improving tobacco control strategies. Ethical approval will be obtained, and informed consent will be taken from participants. Findings will contribute to developing effective, culturally relevant tobacco control policies aimed at reducing smoking prevalence globally.

 
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