Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals
NCT ID: NCT06488443
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
96 participants
INTERVENTIONAL
2024-11-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
NCT01423578
Examining Yoga's Effects on Smoking
NCT02181179
Yoga for Smoking Cessation Feasibility Study
NCT01030068
Hatha Yoga for Smoking Cessation
NCT01633632
Yoga as a Complementary Therapy for Smoking Cessation
NCT01809678
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim: To study the feasibility of yoga in reducing craving in individuals who use tobacco
Objectives:
Primary
* To evaluate the feasibility of yoga based intervention on craving in tobacco dependent individuals who want to quit tobacco use Secondary/tertiary
* To assess the effect on abstinence
* To assess quit rate
Sampling frame:
Screened positive participants will be recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology, oncology, ENT and dental surgery and other super speciality OPD at SJMCH
.
Sample recruitment/sampling method:
Participants who fulfilled the inclusion criteria will be approached by the principal investigator and/or junior research fellow, and those who agreed to participate in the study will be randomly allocated to one of two groups via simple randomization. Randomisation will be computerised. This will be done in blocks of 10. Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants.
Training/ interventions/assessments/ procedures in the study -Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.
Procedure:
Screening positive participants fulfilling eligibility criteria, information regarding study is given and informed consent is documented. Selection of a quit date within 21 weeks.
Standard of living index(SLI) or Modified Kuppuswamy Scale for sociodemographic data (10mins), Fagerstrom scale(5 mins), Motivation to stop smoking (1 min) .
Participants are randomized into intervention and TAU groups with 48 participants each.
For intervention group, sixty minute yoga session will be imparted. The first session shall be offline, the rest of the 6 sessions shall be online.. After Completion all assessments will be done again both of intervention and TAU groups.Follow up at 21 weeks, 1 month and at 3 months.
-To assess relapse
Hypothesis Yoga will be a feasible method to reduce craving in tobacco dependent individuals who want to quit tobacco use
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention-yoga
Participants in intervention arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser. One week of yoga intervention with the first session offline and the rest of the 6 sessions online
Yoga
Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.All the yoga exercises selected for this study are low-impact and involve highly controlled movements. All yoga exercises will be taught and supervised by a skilled yoga-instructor. The yoga-instructor will take great care to emphasize to participants that they should not go beyond their usual range of motion/comfort for any of the yoga exercises.
WHO 5As model intervention
The control group will be given the WHO 5As model intervention to help patients ready to quit.
WHO 5As model intervention
WHO 5As model to help patients ready to quit. The five major steps to intervention are the "5 A's": Ask, Advise, Assess, Assist, and Arrange.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Yoga
Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.All the yoga exercises selected for this study are low-impact and involve highly controlled movements. All yoga exercises will be taught and supervised by a skilled yoga-instructor. The yoga-instructor will take great care to emphasize to participants that they should not go beyond their usual range of motion/comfort for any of the yoga exercises.
WHO 5As model intervention
WHO 5As model to help patients ready to quit. The five major steps to intervention are the "5 A's": Ask, Advise, Assess, Assist, and Arrange.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* -Men aged 18 to 65 years
* -Recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology, oncology, ENT and dental surgery and other superspeciality OPD at SJMCH
Exclusion Criteria
* -Patients with clinical diagnosis of Intellectual disability
* -Comorbid Major mental illness including Dementia, Psychosis, Recurrent depressive disorder, Bipolar affective disorder, OCD, generalized anxiety disorder, Panic disorder and Phobias, diagnosed within the last 6 months.
* -Patients with recent MI and stroke in the last 3 months or those physically unable to perform the yoga postures due to physical disabilities determined by clinical interview.
* -Patients with severe hypertension(SBP≥180mmHg and BP≥120mmHg)
* -Patients with seizures disorder
* -Patients with COPD(GOLD-2,3 and 4)
18 Years
65 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fogarty International Center of the National Institute of Health
NIH
St.John's Medical College and Hospital
UNKNOWN
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vishwajit Nimgaonkar, MD PhD
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vishwajit Nimgaonkar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St.John's Medical College and Hospital
Bengaluru, Karnataka, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY23050176
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.