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CTRI Number  CTRI/2023/03/050989 [Registered on: 22/03/2023] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A good method to stop the tobacco smoking habit 
Scientific Title of Study   Effectiveness of various interventions for smoked tobacco cessation among Chhattisgarh Population - a randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milind Wasnik 
Designation  Professor & Head 
Affiliation  Govt. Dental College Raipur 
Address  Govt. Dental College Raipur Chhattisgarh

Raipur
CHHATTISGARH
441904
India 
Phone  9403162220  
Fax    
Email  drmilind.pcd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavana Dave 
Designation  Professor & Head 
Affiliation  K M Shah Dental College Vadodara 
Address  K M Shah Dental College Piparia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9998034036  
Fax    
Email  bhavnadave1964@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Milind Wasnik 
Designation  Professor & Head 
Affiliation  Govt. Dental College, Raipur 
Address  Govt Dental College Raipur Chhattisgarh

Raipur
CHHATTISGARH
441904
India 
Phone  9403162220  
Fax    
Email  drmilind.pcd@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College Raipur Chhattisgarh 
Self 
 
Primary Sponsor  
Name  Dr Milind Wasnik 
Address  Govt. Dental College Raipur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
State Nodal Officer NTCP  State Tobacco Control Cell Chhattisgarh State 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Milind Wasnik  Govt Dental College Raipur  Tobacco cessation center, Out-patient Department, Department of Public Health Dentistry
Raipur
CHHATTISGARH 		 9403162220

drmilind.pcd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committe (SVIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NRT (Nicotine Replacement therapy) and m-cessation   Ministry of Health & Family Welfare, in partnership with World Health Organisation and the International Telecommunications Union, has started an initiative for utilising mobile technology for tobacco cessation. WHO-ITU‟s „Be Healthy Be Mobile‟ initiative, aims to reach out to tobacco users of all categories who want to quit tobacco use and support them towards successful quitting through constant text messaging on mobile phones. The initiative is fully supported by the Government of India. Content adaptation and web-based messaging were developed by Centre for Addiction Medicine, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore. 
Intervention  NRT Group (Nicotine Replacement Therapy)  Nicotine gums in the dosage of 4 mg per day would be given to those who smoke 25 or more cigarettes per day and 2 mg per day to those who smoke less than 25 cigarettes per day to the NRT group for the entire intervention period and this would be scheduled for 12 weeks as follows: • Weeks 1–6: A piece of gum every 1–2 h • Weeks 7–9: A piece of gum every 2–4 h • Weeks 10–12: A piece of gum every 4–8 h. 
Intervention  The NRT plus counseling group  The participants in the counseling group would be given tobacco cessation directives for a preliminary period of 30 min along with the written materials for reinforcement. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Outpatients at the hospital, within the age band of 18– 60 years
2. Participants who remained current users of “smoking form” of tobacco
3. Confirmed to remain at their current address till the completion of the study.
4. Able to provide written informed consent and understand the study protocol.
5. Access to the mobile phones 
 
ExclusionCriteria 
Details  1. Terminal ailment (prognosis <12 months)
2. Pregnancy
3. Patients under psychiatric care
4. History of hypersensitive reactions toward nicotine or menthol
5. Previous admission into the similar study
6. Patients using both smoking and smokeless variants of tobacco. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of various interventions used for tobacco cessation i.e. which method is more helpful in quitting tobacco habit  Effectiveness of various interventions used for tobacco cessation for Three Months. 
 
Secondary Outcome  
Outcome  TimePoints 
Pharmacotherapy with combination of behavioral therapy would yield in better results.  Effectiveness of various interventions used for tobacco cessation for Three Months. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/04/2023 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Wasnik M, Dave B, Vadher V. Effect of various interventions for smoked tobacco cessation among Indians in Chhattisgarh. Bioinformation. 2025 Feb 28;21(2):225-230. doi: 10.6026/973206300210225. PMID: 40322715; PMCID: PMC12044188. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The current study is aimed to gauge the effectiveness of three different tobacco cessation interventions i.e. NRT (Nicotine Replacement therapy) alone, combination of NRT (Nicotine Replacement therapy) & counseling & combination of NRT (Nicotine Replacement therapy) and m-cessation among Chhattisgarh Population. A prospective, single-blind, randomized controlled interventional study would be carried out among patients attending the Tobacco Cessation Centre at Government Dental College, Raipur, Chhattisgarh, and a total of 150 participants who will satisfy the inclusion and exclusion criteria would be selected for the study. The selected study participants would be randomly and equally assigned to the three intervention groups (50 participants in each group) for a time span of 3 months . Participants were randomized on a 1:1:1 basis to the three groups using block randomization with variable block size of 3. Participants were randomly allocated to three different study groups composed of NRT group (Group I) (12 -week course), a combination of the both (Group II) (counseling intervention (30 min intervention with printed materials) with a 12 -week sequential course of NRT), and mCessation along with NRT (Group III). After intervention period, the abstinence from the tobacco use or decline in the frequency and quantity of tobacco use would be evaluated by a pretested questionnaire and clinical analysis of the participants by measuring the respired CO using the CO monitoring device, Nicotine Cotinine levels will be measured by Nicotine Cotinine tests in urine sample. this will help us to know that which method will be more helpful in quitting tobacco habit. 
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