| CTRI Number |
CTRI/2025/08/092361 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
pre post study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the effect of AUM KARA Meditation on Medical students: A Pre-Post study |
|
Scientific Title of Study
|
Effect of AUM KARA Meditation on Medical students suffering with Insomnia: A Pre-Post Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.JYOTI NAIR |
| Designation |
Principal and Medical Superintendent |
| Affiliation |
Vivekanandha Educational Insututions |
| Address |
vivekanandha Naturopathy and Yoga Medical college
34/1
C.S. garden,
Seelanaikenpatti
Salem
TAMIL NADU
637303
India |
| Phone |
9047705939 |
| Fax |
|
| Email |
jyotinairbnys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Nair |
| Designation |
Principal and Medical Superintendent |
| Affiliation |
Vivekanandha Educatonal Institutions |
| Address |
Swamy Vivekanandha Naturopathy and Yoga Medical college and Hospital
34/1
C S Garden
Seelanaikenpatti
Salem
Salem
TAMIL NADU
637303
India |
| Phone |
9047705939 |
| Fax |
|
| Email |
jyotinairbnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathya Joicy M |
| Designation |
Assistant Professor and Medical officer |
| Affiliation |
Vivekanandha Educational Institutions |
| Address |
Department of Physiology
Swamy Vivekanandha Naturopathy and Yoga Medical college and Hospital
63-1
Teachers colony
OMALUR TK AND PO
Salem
TAMIL NADU
637303
India |
| Phone |
9345828099 |
| Fax |
|
| Email |
sathyajoicy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swamy Vivekanandha Educational Institutions
Sankagiri
SALEM
Pin code 637303 |
|
|
Primary Sponsor
|
| Name |
Swamy Vivekanandha Naturopathy and Yoga Medical college |
| Address |
Veerachipalayam
Sankagiri, Pin - 637303
SALEM- DT
TAMILNADU
INDIA |
| 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 |
| Dr Sathya Joicy M |
Swamy Vivekanandha Naturopathy and Yoga Medical College |
Yoga hall
Dept. of Yoga
Veerachipalayam
Sankagiri
Salem
TAMIL NADU |
9345828099
sathyajoicy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VivekanandhaInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep Disturbances |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Both |
| Details |
Medical students from 1st year to 4th year studying at Swamy Vivekanandha Naturopathy and Yoga Medical College, suffering with sleep disturbances and should not be on medication
|
|
| ExclusionCriteria |
| Details |
Severely Medically ill students suffering with diseases like Asthma, Migraine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce sleep disturbances
To improve their sleep quality |
pre data - Preliminary
post data - on the 11th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve mental activity |
DAY 1 - PRE OR PRELIMINARY DATA
DAY 11 - POST DATA |
|
|
Target Sample Size
|
Total Sample Size="222"
Sample Size from India="222"
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)
|
07/06/2026 |
| 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="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To access the effect of AUM kara meditation on Medical students suffering with sleep disturbances this study is undertaken The Meditation will be given for 30 minutes daily for 10 days and after that the results are analyzed through Questionnaire and scales |