| CTRI Number |
CTRI/2023/10/058779 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of yoga on reducing craving in tobacco dependent individuals
|
|
Scientific Title of Study
|
Randomized control study to study the effect of yoga on reducing craving in tobacco dependent individuals who want to quit tobacco use |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jewel Johns |
| Designation |
Post Graduate |
| Affiliation |
St Johns Medical College Hospital, Bangalore |
| Address |
Department of Psychiatry,St Johns Medical College,Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bengaluru, Karnataka
Bangalore
KARNATAKA
560034
India |
| Phone |
9902487374 |
| Fax |
|
| Email |
drjohns.jewel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Sreedaran |
| Designation |
Associate Professor |
| Affiliation |
St Johns Medical College Hospital, Bangalore |
| Address |
Department of Psychiatry,St Johns Medical College,Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bengaluru, Karnataka
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065570 |
| Fax |
|
| Email |
priya.s@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Jewel Johns |
| Designation |
Post Graduate |
| Affiliation |
St Johns Medical College Hospital, Bangalore |
| Address |
Department of Psychiatry,St Johns Medical College,Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bengaluru, Karnataka
Bangalore
KARNATAKA
560034
India |
| Phone |
9902487374 |
| Fax |
|
| Email |
drjohns.jewel@gmail.com |
|
|
Source of Monetary or Material Support
|
| University of Pittsburgh,4200 Fifth Ave, Pittsburgh, PA 15260, United States |
|
|
Primary Sponsor
|
| Name |
Jewel Johns |
| Address |
Department of Psychiatry,St Johns Medical College,Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bengaluru, Karnataka |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| University of Pittsburgh |
University of Pittsburgh,4200 Fifth Ave, Pittsburgh, PA 15260, USA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jewel Johns |
St Johns Medical College Hospital, Bangalore |
Non-COVID OPD and Super speciality block OPD
Bangalore
KARNATAKA |
9902487374
drjohns.jewel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,St Johns Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
WHO 5As model to help patients ready to quit |
Patients will be provided the standard WHO 5As model for patients who want to quit. |
| Intervention |
Yoga based intervention for craving in tobacco dependent individuals |
Participants in intervention arm will receive yoga intervention. This intervention will be administered by a yoga instructor. The first session will be offline while the rest of the 6 sessions will be online. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.Tobacco dependent individuals (Fagerstrom test for tobacco dependence score more than or equal to 4)
2.Men aged 18 to 65 years
3.Recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology,ENT and dental surgery and other super speciality OPD at SJMCH
|
|
| ExclusionCriteria |
| Details |
1.Patients with recent alcohol use (last 3 months) and use of other drugs of abuse
2.Patients with clinical diagnosis of Intellectual disability
3.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.
4.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
5.Patients with severe hypertension(SBP≥180mmHg and BP≥120mmHg)
6.Patients with seizures disorder
7.Patients with COPD
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the feasibility of yoga in reducing craving in individuals who use tobacco |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Quit Rate
2. Relapse
3.Abstinence |
2 weeks, 1 month & 3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We aim to evaluate the feasibility of yoga- based intervention on craving in tobacco dependent individuals who want to quit tobacco use using a single-site, parallel group, two-arm randomised controlled trial design in 96 participants. The eligible and consenting participants will be screened for tobacco dependence on Fagerstrom scale. A quit date will be selected within 2 weeks. The participants in yoga arm will receive a yoga intervention by a yoga instructor. The first session will be offline while the rest of the 6 sessions will be online. Motivation to stop smoking scale and Brief Questionnaire of Smoking Urges would be used. Participants in intervention arm will receive yoga intervention and control group will receive WHO 5As model. Questionnaire of Smoking Urges and the Visual Analogue Scale will be repeated at the end of 2 weeks of yoga. Participants that relapse can rejoin the group they belonged to. Participants will be encouraged to use the techniques they have learned to overcome craving. Quit rate, relapse and abstinence will be assessed at 2 weeks, 1 month and 3 months follow ups |