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Comparing the Success of Two Methods to Help People Quit Tobacco in Delhi: Counseling with Nicotine Gum and Health Risk Information vs. Counseling with Nicotine Gum Alone

EFFECTIVENESS OF MOTIVATIONAL TOOL BASED ON BIOMEDICAL RISK ASSESSMENT AS AN ADJUNCT FOR TOBACCO CESSATION TREATMENT AMONG TOBACCO USERS IN DELHI: RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241130001
Enrollment
160
Registered
2024-11-30
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Users Tobacco Cessation Tobacco Use Risk Assessment Randomized Control Trial

Interventions

Brief Behaviour counselling with nicotine gums as pharmacotherapy and biomedical test including-Pulmonary function test, Hematological Parameters, Perceived Stress levels, BMI and Cotinine Test as a m
Experimental Behavioral,Active Comparator Behavioral
Behaviour counselling, Nicotine gums and Biomedical Risk assessment Tool ,Behaviour counselling and Nicotine gum

Sponsors

Mrinali Gupta
Lead Sponsor
Dr. Aswini Y Balappanavar
Collaborator

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Smokeless, smoke form or dual tobacco users. 2 Using any form of tobacco for 6 months or more. 3 All patients consuming tobacco in contemplation and preparation stage when assessed.

Exclusion criteria

Exclusion criteria: 1 Patients who are medically compromised and have diseases which are contraindications for nicotine gum use. 2 Patients who have received tobacco cessation counselling in the past six months. 3 Patients already diagnosed with lung and hematological disorders. 4 Other exclusions included pregnant females, substance abuse and those undergoing psychiatric treatment.

Design outcomes

Primary

MeasureTime frame
tobacco quit status Baseline and 6th month Cotinine test

Secondary

MeasureTime frame
Lung function test Baseline, 3rd month and 6th month Spirometer,Hematological parameters Baseline, 3rd month and 6th month CBC, LFT,KFT, Lipid Profile, FBS,Perceived stress Levels Baseline, 3rd month and 6th month Perceived Stress Scale,Withdrawal Symptoms Baseline, 3rd month and 6th month Self Reported,Confidence Levels Baseline, 3rd month and 6th month Confidence scale

Countries

India

Contacts

Public ContactMrinali gupta

Maulana Azad Institute of Dental Sciences

mrinali208@gmail.com09654067820

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026