| CTRI Number |
CTRI/2025/12/098895 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Om meditation effect on college students |
|
Scientific Title of Study
|
Study of Om meditation intervention on academic performance Sleep, Stress and cardiac activity among college students |
| 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 Madhur |
| Designation |
BNYS, PhD Scholar |
| Affiliation |
MASCHNYS |
| Address |
Room No.1, Naturopathy & Yoga Dept. Subharti University Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Madhur |
| Designation |
BNYS, PhD Scholar |
| Affiliation |
MASCHNYS |
| Address |
Room No.1, Naturopathy & Yoga Dept. Subharti University Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Madhur |
| Designation |
BNYS, PhD Scholar |
| Affiliation |
MASCHNYS |
| Address |
Room No.1, Naturopathy & Yoga Dept. Subharti University Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Naturopathy & Yoga Dept. Subharti University Meerut Uttar Pradesh India (Pin.250005) |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti Madhur |
| Address |
Naturopathy & Yoga Dept. Subharti University Meerut Uttar Pradesh India (Pin.250005) |
| Type of Sponsor |
Other [Self] |
|
|
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 Jyoti Madhur |
Room No.1, Naturopathy & Yoga Hospital |
Naturopathy & Yoga Dept. Subharti University Meerut Uttar Pradesh, 250005
Meerut
UTTAR PRADESH |
9758497123
jyotimadhur05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Om meditation |
Individual will sit and follow meditation procedure for 45 min.for 1 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate
Students from BNYS and MD |
|
| ExclusionCriteria |
| Details |
Pregnant women
Individuals diagnosed with any acute & chronic health condition
Psychological illness or taking prescribed medicine that may alter HRV |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HRV (Heart Rate Variability) |
0, at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pittsburgh Sleep Quality Index (PSQI)
Perceived Stress Questionnaire (PSQ) |
0, at 4 weeks |
|
|
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)
|
22/12/2025 |
| 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="1"
Months="8"
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
|
this study will see om meditation effect on students Heart rate variability, Stress, sleep and academic pefformance. METHOD: The patient will lie supine and pre-HRV (Heart rate Variability) recordings will be taken.
Perceived Stress Questionnaire (PSQ), Attendance, Average Grade point, and Pittsburgh Sleep
Quality Index
(PSQI) will also be obtained. The individual will be administered the Practice of Om meditation daily for 45 min. For 1
month. After 1 month the post-HRV will be taken along with the Perceived Stress Questionnaire (PSQ),
Attendance, Average Grade point, and Pittsburgh Sleep Quality Index (PSQI). |