| CTRI Number |
CTRI/2025/08/093783 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Meditation] |
| Study Design |
Other |
|
Public Title of Study
|
"Studying the Impact of Meditation on Brain Activity and Heart Health in College Students Under Academic Stress" |
|
Scientific Title of Study
|
EFFECT OF MEDITATION ON P300 AND HEART RATE VARIABILITY IN UNDERGRADUATES UNDERGOING ACADEMIC WORKLOAD |
| 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 SUTHIMA A K |
| Designation |
JUNIOR RESIDENT (POST GRADUATE - 1) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 247, Second floor, Department of Physiology, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
NIL
Central
DELHI
110002
India |
| Phone |
8940470084 |
| Fax |
|
| Email |
tell2suthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Swami |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology, Second Floor, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
NIL
Central
DELHI
110002
India |
| Phone |
9999000993 |
| Fax |
|
| Email |
swamidoctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUTHIMA A K |
| Designation |
JUNIOR RESIDENT (POST GRADUATE - 1) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 247, Second floor, Department of Physiology, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
NIL
Central
DELHI
110002
India |
| Phone |
8940470084 |
| Fax |
|
| Email |
tell2suthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr SUTHIMA A K |
| Address |
Department of Physiology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi. |
| 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 SUTHIMA A K |
Maulana Azad Medical College |
Room no:244 ANS lab and Room no:228 NCV lab, Department of Physiology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002
Central
DELHI |
8940470084
tell2suthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional of Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Academic work load |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Meditation |
ISHA KRIYA |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
1. Male healthy undergraduate medical students.
2. Age between 18 to 25 years. |
|
| ExclusionCriteria |
| Details |
1. Subjects already practicing meditation.
2. Subjects with any auditory deficit or attentional impairment.
3. Subjects on any medication or herbal remedy.
4. History of any major illness, particularly psychiatric, neurological, cardiac or respiratory disorders.
5. Recent history of exposure to a neurotoxic agent like heavy metals or abuse of illicit drugs.
6. History of alcohol intake and smoking.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean improvement in the amplitude and latency of P300 after practicing meditation post academic workload. |
Baseline and six weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean improvement in heart rate variability after practicing meditation caused by academic workload. |
Baseline and six weeks. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/09/2025 |
| 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="1"
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
|
This study will be conducted in ANS lab and NCV lab room, Department of Physiology, Maulana Azad Medical College. The current study aims to evaluate the effect of meditation on P300 and heart rate variability in undergraduates undergoing academic workload. This study is expected to serve as both an assessment tool and a source of inspiration for exploring the impact of meditation, with the goal of improving performance, effectiveness, and efficiency. |