| CTRI Number |
CTRI/2025/08/093048 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Inter-professional health education] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Reductions in Addictions Among School Going Adolescents |
|
Scientific Title of Study
|
Effectiveness of Interprofessional health team educational
intervention with ashtanga yoga for adolescent addictions among school
going children: A cluster randomized control trial.
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B N Mahima |
| Designation |
Public Health Consultant |
| Affiliation |
Sri Devraj urs Academy of Higher Education and Research |
| Address |
Department of community medicine, SDUMC, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
8722625719 |
| Fax |
|
| Email |
mahimabn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B N Mahima |
| Designation |
Public Health Consultant |
| Affiliation |
Sri Devraj urs Academy of Higher Education and Research |
| Address |
Department of community medicine, SDUMC, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
8722625719 |
| Fax |
|
| Email |
mahimabn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B N Mahima |
| Designation |
Public Health Consultant |
| Affiliation |
Sri Devraj urs Academy of Higher Education and Research |
| Address |
Department of community medicine, SDUMC, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
8722625719 |
| Fax |
|
| Email |
mahimabn@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SDUAHER |
| Address |
Sri Devraj urs Academy of Higher Education and Research, Tamaka Kolar 563101 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mahima B N |
Sri Devaraj Urs Medical College |
Room no - 23,2nd Floor,College Building
Department Of Community Medicine,
Sri Devaraj Urs Medical College,SDUAHER,
Tamaka,Kolar,Karnatak,INDIA-563101.
Kolar
KARNATAKA |
8722625719
mahimabn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents from government high schools |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health Education |
Health education for 8 weeks on various addiction |
| Intervention |
Inter-professional Health team education with Yoga |
Health education on various addictions with Ashtanga Yoga |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
School going adolescent children in the district of Kolar |
|
| ExclusionCriteria |
| Details |
Non school going children in the district of Kolar |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in addictions with health education and ashtanga yoga |
8 Weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="1110"
Sample Size from India="1110"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
addiction is a chronic disorder charcterised by the compulsive use of a substance or engagement in behavior despite harmful consequences. the present study will be encouraging the students to include yoga and meditation as a part of daily routines which can help individuals manage addictions related stress and address concerns related to addiction by promoting relaxation and mental well-being |