| CTRI Number |
CTRI/2025/11/097866 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to know quitting of tobacco among tobacco chwewers after habit cessation counselling and nicotine replacement therapy |
|
Scientific Title of Study
|
Cessation of Smokeless Tobacco Use Assessing the combined effectiveness of Nicotine replacement therapy and Tobacco cessation counselling in achieving abstinence from smokeless tobacco use by evaluating quit rates three months post intervention A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAkshata Agnihotri |
| Designation |
Assistant Professor |
| Affiliation |
SDM College Of Dental science and Hospital |
| Address |
Public Health Dentistry Department , SDM College of dental sciences and Hospital, Dhavalnagar,Sattur.
Department 10,SDM College of dental sciences and Hospital, Dhavalnagar,Sattur.
Dharwad
KARNATAKA
580009
India |
| Phone |
09620996149 |
| Fax |
|
| Email |
sdm.akshata2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Shirahatthi |
| Designation |
Professor and Head |
| Affiliation |
SDM College Of Dental science and Hospital |
| Address |
Public Health Dentistry, Department, SDM College of dental sciences and Hospital, Dhavalnagar,Sattur.
Department 10, SDM College of dental sciences and Hospital, Dhavalnagar,Sattur.
Dharwad
KARNATAKA
580009
India |
| Phone |
7259229908 |
| Fax |
|
| Email |
shirahattiravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAkshata Agnihotri |
| Designation |
Assistant Professor |
| Affiliation |
SDM College Of Dental science and Hospital |
| Address |
Public Health Dentistry Department , SDM College of dental sciences and Hospital, Dhavalnagar,Sattur.
Department 10, SDM College of dental sciences and Hospital, Dhavalnagar,Sattur.
Dharwad
KARNATAKA
580009
India |
| Phone |
09620996149 |
| Fax |
|
| Email |
sdm.akshata2023@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.K.Handoo Scholarship, Indian cancer society, National Head Quarters, 74, Jerbai Wadia Road, Bhoiwada, Parle Mumbai- 400012 |
|
|
Primary Sponsor
|
| Name |
Indian Cancer Society Mumbai |
| Address |
NAtional HArd quarters, 74, Jerbai Wadia Road, Bhoiwada, Parel, Mumbai- 400012 |
| Type of Sponsor |
Other [Indian cancer society ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SDM College of Dental Sciences and Hospital Sattur SDM University Dharwd |
Department of Public Health Dentistry, SDM College of Dental Sciences and Hospital Sattur,
SDM University, Dharwd 580009 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAkshata Agnihotri |
Public Health Dentistry, SDM College of dental sciences and Hospital, |
Public Health Dentistry, SDM College of dental sciences and Hospital, Dhavalnagar,Sattur.
Dharwad
KARNATAKA |
09620996149
sdm.akshata2023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCDS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tobacco Chewing Habit Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Tobacco Cessation counselling from the dentist.5 As (Ask, Advice, Assess, Assist, Arrange) brief intervention method is used. Dummy patches will be used as a placebo for the druation of three months |
| Intervention |
Tobacco cessation counseling and Nicotine Replacement Therapy |
Tobacco Cessation counselling from the dentist.5 As (Ask, Advice, Assess, Assist, Arrange) brief intervention method is used.
NRT Patch Prescription: The intervention group will be prescribed Nicotine Replacement Therapy (NRT) patches based on their SLT usage:
20 or more SLT per day:
14 mg patches for 6 weeks
14 mg patches for an additional 4 weeks
7 mg patches for the final 2 weeks
10 to 19 SLT per day:
14 mg patches for 4 weeks
7 mg patches for the following 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients attending oral cancer screening campaign
Those who use smokeless form of tobacco or mixed.
Who have tried quitting for atleast one week in past two months and failed and still willing to quit.
Those who have responded during the follow up phone calls after enrolling in the camps.
Patients from Tobacco cessation center at the hospital who have tried quitting for atleast one week in past two months and failed and still willing to quit.
Patients aged 18 and above.
|
|
| ExclusionCriteria |
| Details |
Who use exclusively smoking form of tobacco.
Who are not willing to quit the habit.
Patients with pre cancerous oral lesions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate quit rates of smokeless-tobacco use
after tobacco cessation cunselling and Nicotine replacement therapy intervention. |
To evaluate quit rates of
at the end of 12 weeks after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of tobacco use,
willingness to quit and
associated oral lesions among those attending
oral cancer screening camps/ hospital visit for habit cessation
- To estimate the follow up rates for those
identified with oral lesions
at oral cancer screening campaign/ hospital visit for habit cessation
- To estimate the cost effectiveness of the
program in terms of quit
rates achieved.
- To evaluate the influence of demographic
factors, type of tobacco
used and degree of tobacco dependence on the
quit rates. |
three months |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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)
|
01/01/2026 |
| 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) |
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sdm.akshata2023@gmail.com].
- For how long will this data be available start date provided 24-12-2024 and end date provided 12-07-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a Randomization control trial Duration: six months (Recruitment: 1 month, Follow up 3 months, Data analysis and presentation: 2 months) • Follow up: three months • Based on inclusion and exclusion criteria the volunteers will be recruited in the study. ORAL CANCER SCREENING • subjects attending oral cancer screening campaign and Tobacco Cessation Center . • Participants who consume smokeless tobacco, have tried quitting atleast one week and willing to participate will be selected in the study. • Demographic data (Name, age, gender, education, family income, occupation) will be collected. • Participants will be questioned regarding their habits – type, amount, frequency and duration. • Intra oral examination will be done and detection of commonly seen lesions like leukoplakia, erythroplakia, oral submucous fibrosis and tobacco pouch keratosis. • Participants detected with lesions will be separately followed up for the treatment. • Dentition status of the participants will be examined. • An informed consent will be taken prior to the study from the participants who are willing to take part in the study.
PHASE 2: • Volunteers will be divided into two groups with details of the intervention and control as follows: Intervention group will receive intensive counselling by
the dentist similar to the control group. In addition, they will receive the
Nicotin replacement therapy intervention. Follow-up will be done for 3 months Control group will receive intensive tobacco
cessation counselling by dentists(Ask and Advise component of the intervention)
and placebo therapy. • After three months follow up quit rates will be assessed by Cotinine test kit for those participants who claim to have quit the habit. |