| CTRI Number |
CTRI/2024/11/076886 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Yoga on Relapse Prevention on Alcohol Dependent Patients- A Randomized Controlled Open-Label Superiority Trial |
|
Scientific Title of Study
|
Effectiveness Of Yoga On Relapse Prevention and Influence of Quality Of Life And Perceived Social Support on Alcohol
Dependent Patients Versus Conventional Treatment at Various
Health Care Facilities in Dakshina Kannada District- A
Randomized Controlled Open Label Superiority 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 |
Inchara S |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medial College, Light House Hill Road Mangalore – 575 001 91-0824-2422271, EXT 5504 |
| Address |
Department of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Mangaluru 575001, Dakshina Kannada District, Karnataka, India.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6360190917 |
| Fax |
|
| Email |
inchara.kmcmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keshava Pai K |
| Designation |
Professor and H.O.D, Department of Psychiatry |
| Affiliation |
Kasturba Medical College. Light House Hill Road Mangalore – 575 001 91-0824-2422271, EXT 5504 |
| Address |
Department of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Mangaluru 575001, Dakshina Kannada District, Karnataka, India.
Dakshina Kannada
KARNATAKA
577001
India |
| Phone |
9448105227 |
| Fax |
|
| Email |
pai.keshava@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Inchara S |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical Collge, Light House Hill Road Mangalore – 575 001 91-0824-2422271, EXT 5504 |
| Address |
Department of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Mangaluru 575001, Dakshina Kannada District, Karnataka, India.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6360190917 |
| Fax |
|
| Email |
inchara.kmcmlr2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education (MAHE), Madhav Nagar, Manipal, Udupi Karnataka,
576104 India |
|
|
Primary Sponsor
|
| Name |
Inchara S |
| Address |
Department of Psychiatry Kasturba Medical College, Mangalore. Dakshina Kannada. Karnataka. 575001 |
| Type of Sponsor |
Other [Self-Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Keshava Pai K |
Kasturba Medical College Hospital, Attavar Mangalore |
Department of Psychiatry, Room No.14, KMC HospitaL Attavar, Nandigudda Rd. Attavar, Mangalore,575002,Dakshina Kannada. KARNATAKA. India.
Dakshina Kannada
KARNATAKA |
9448105227
pai.keshava@manipal.edu |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Yoga Capsule for Substance Use |
Post-test data will be analyzed after completion of the Yoga capsule. Statistical T-test will be performed to identify Pre-test and Post-test differences/changes. |
| Intervention |
Yoga Capsule for Substance Use |
The Capsule has 8 Different Techniques, including the Instant Relaxation Technique, Deep Abdominal Breathing, Forehead Shining Breath, Breath of Victory, and others. The practice of yoga capsules will help to prevent relapse in Alcohol Dependent patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Use of only Alcohol and Tobacco substances.
Patients with Kannada or English language knowledge
Patients who are hospitalized / in OPD and De-addiction centers in Dakshina Kannada |
|
| ExclusionCriteria |
| Details |
Alcohol dependent patients who are diagnosed with any other psychiatry illness or are undergoing any other treatment for psychiatry illness
Alcohol-dependent patients with severe health complications such as liver problems, diabetes,
cardiovascular disease, disease of muscle tissue, pancreas inflammation
Relapse within the study timeline then participants will be excused from the study
Pregnancy or post-partum (till 8 Weeks) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
36 sessions, 3 month, 6 month, 9 month, 12 month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived Social support, Self-Efficacy |
36 sessions, 3 month, 6 month, 9 month, 12 month follow-up |
| Loneliness, Perceived stigma |
36 sessions, 3 month, 6 month, 9 month, 12 month follow-up |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 1 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study aims to evaluate the Effectiveness of Yoga compared to conventional treatment in maintaining abstinence in Alcohol Dependent patients in various healthcare facilities. Considering the relapse is the recurrent factor of alcohol dependence. This study will evaluate if yoga will be an effective tool to counteract the relapse and maintain the period of abstinence, loneliness, and stigma associated with alcohol dependence and how it can help in promoting the quality of life, perceived social support, and self-efficacy of the patients. It also encourages Goal 3 of the Sustainable Development Agenda (SDG) of 3.5 -Strengthen the prevention and treatment of substance abuse, including narcotic drug abuse and harmful use of alcohol. |