| CTRI Number |
CTRI/2022/07/043815 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
THE EFFECT OF BEHAVIOURAL MODIFICATION THERAPY ON TOBACCO CESSATION |
|
Scientific Title of Study
|
THE EFFECT OF BEHAVIOURAL MODIFICATION THERAPY ON TOBACCO CESSATION AMONG PATIENTS VISITING A DENTAL INSTITUTION IN BANGALORE – AN EXPERIMENTAL STUDY. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARUMUGAM P M |
| Designation |
Post Graduate Student, Department of public health dentistry |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari dental college and hospital No 14 ramohalli cross mysore road Bangalore - 74
Rajarajeswari dental college and hospital No 14 ramohalli cross mysore road Bangalore - 74
Bangalore
KARNATAKA
560074
India |
| Phone |
9942828607 |
| Fax |
|
| Email |
aarumugampm27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanna Kumar Y S |
| Designation |
Professor, Department of public health dentistry |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
No 14. ramohalli cross, Mysore road, Bangalore - 74
Bangalore
KARNATAKA
560074
India |
| Phone |
9901297908 |
| Fax |
|
| Email |
yspkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARUMUGAM P M |
| Designation |
Post Graduate Student, Department of public health dentistry |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari dental college and hospital No 14 ramohalli cross mysore road Bangalore - 74
Rajarajeswari dental college and hospital No 14 ramohalli cross mysore road Bangalore - 74
Bangalore
KARNATAKA
560074
India |
| Phone |
9942828607 |
| Fax |
|
| Email |
aarumugampm27@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARUMUGAM P M
Post Graduate Student, Department of Public Health Dentistry, Rajarajeswari Dental College and Hospital, Bangalore - 560074 |
|
|
Primary Sponsor
|
| Name |
ARUMUGAM P M |
| Address |
Rajarajeswari Dental College and Hospital No 14 Ramohalli cross mysore road Bangalore |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ARUMUGAM P M |
Rajarajeswari dental college and hospital |
Rajarajeswari dental college and hospital.
Department of Public Health and Dentistry.
Room NO 8.
No 14 romahalli cross mysore road Bangalore 560074
Bangalore
KARNATAKA |
9942828607
aarumugampm27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari dental college and hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ready to quit smoking or smokeless tobacco use |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioral modification therapy |
a key aspect of the significance of motivational, barriers and benefits of quitting and relapse, pros and cons of nicotine fading, merits of telephonic follow up, efficaciousness and quit attempts. These interventions furnish support and hope, learning on educational and coping skills to the participants.
Follow up was done at the interval of 10 days, 30 days, 3 months, and 6 months. All the technique were reinforced again at the follow-up.
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Participants who will give informed consent to participate in the study.
• Patients aged between 18 - 80yrs.
• Patients using tobacco for more than 6 months.
• A patient using tobacco for more than 3 times per day.
• No subjects should have undergone any behavioural counselling in the four-week period prior to the baseline examination.
|
|
| ExclusionCriteria |
| Details |
• Participants who don’t give informed consent to participate in the study.
• Pregnant or lactating females.
• Patient undergoing nicotine replacement therapy.
• Those who are undergoing antibiotic or anti-inflammatory therapy or on medication for any underlying systemic disorders
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| reduction in the consumption a number of cigarettes smoked and smokeless tobacco |
baseline, 10th day, 30th day, 3 months, 6 months. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the complete abstinence for any form of tobacco use for at least a month |
after six months |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
India occupies a very special place in the world’s tobacco map. As the second most populous country in the world, India’s share of the global burden of tobacco induced disease and death is substantial and as the second largest producer and consumer of tobacco in the world.
|