| 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
|
|
|
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
|
|
|
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. |