| CTRI Number |
CTRI/2026/02/103398 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of acute psychological stress on cardiovascular and heart rate variability(HRV) reactivity in subjects with dyslipidemia. |
|
Scientific Title of Study
|
Effect of acute psychological stress on cardiovascular and heart rate variability(HRV) reactivity in subjects with dyslipidemia. |
| 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 Raunak Kumar |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical Cllege |
| Address |
2A 53 Second Floor Ramesh Nagar New Delhi Kirti Nagar West Delhi 110015 INDIA
West
DELHI
110015
India |
| Phone |
7250896729 |
| Fax |
|
| Email |
DRRAUNAKKUMAR9999@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mona Bedi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 242 Department of Physiology Maulana Azad Medical College New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9990499927 |
| Fax |
|
| Email |
drmonabedi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Swami |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology Maulana Azad Medical College New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9999000993 |
| Fax |
|
| Email |
swamidoctor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Raunak Kumar |
| Address |
2a 53 Second Floor Ramesh Nagar New Delhi Kirti Nagar West Delhi 110015 |
| 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 RAUNAK KUMAR |
MAULANA AZAZ MEDICAL COLLEGE |
BAHADUR SHAH ZAFAR MARG NEW DELHI 110002
New Delhi
DELHI |
7250896729
DRRAUNAKKUMAR9999@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
a. Age group between 18 to 45 years.
b. Literate subjects at least 10th class completed.
c. Body mass index between 18,5 to 22,5 kg per metre square.
d. Subjects with mild to moderate dyslipidaemia diagnosed as per Indian guidelines for dyslipidaemia criteria will be recruited from L.N.J.P hospital.
e, In control group healthy individuals of age group 18 to 45 years will be recruited who do not have dyslipidaemia. |
|
| ExclusionCriteria |
| Details |
a Personal habits of smoking and alcohol intake.
b. Individuals diagnosed with any neuropsychiatric illness.
c. paternal history of hypertension or diabetes mellitus or thyroid disorders.
d. History of acute heart diseases and those who are equipped with pacemaker devices. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Heart Rate Variability |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess cardiovascular reactivity to acute psychological stress in subjects with dyslipidaemia
2. to use the results obtained as a tool for screening the dyslipidaemia subjects who are more prone to develop cardiovascular diseases.
3. blood pressure & heart rate
4. Lipid profile if last 3 month lipid profile report is not available |
10 to 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
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
|
Heart Rate Variability is a noninvasive electrocardiographic indicator which can be used to measure the effect of stress on Autonomic nervous system function. Recent studies have shown a significant correlation between elevated serum lipid profiles and sustained increase in sympathetic tone. |