| CTRI Number |
CTRI/2026/04/107949 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Non-Invasive Test to Check Cardiovascular autonomic Health in Healthy Elderly |
|
Scientific Title of Study
|
Evaluation of Cardiovascular Autonomic Function Using NIBRA-CS® in Otherwise Healthy Elderly |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Tripathi |
| Designation |
Director |
| Affiliation |
Inovocare Healthsoft Solutions |
| Address |
Inovocare Healthsoft Solutions 377, Purbalok Kolkata
Kolkata
WEST BENGAL
700099
India
Kolkata WEST BENGAL 700099 India |
| Phone |
9748843499 |
| Fax |
|
| Email |
trohan747@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shatavisa Mukherjee |
| Designation |
Senior Research Officer |
| Affiliation |
School of Tropical Medicine, Kolkata |
| Address |
Room No 19
Department of Clinical and Experimental Pharmacology
108, Chittaranjan Avenue
Kolkata
WEST BENGAL
700073
India
Kolkata WEST BENGAL 700073 India |
| Phone |
9830529192 |
| Fax |
|
| Email |
shatavisa100@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shatavisa Mukherjee |
| Designation |
Senior Research Officer |
| Affiliation |
School of Tropical Medicine, Kolkata |
| Address |
Room no 19
Department of Clinical and Experimental Pharmacology
108, Chittaranjan Avenue
Kolkata
WEST BENGAL
700073
India
Kolkata WEST BENGAL 700073 India |
| Phone |
9830529192 |
| Fax |
|
| Email |
shatavisa100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Diabetes and Allergy Asthma Therapeutics Specialty Clinic
Room No 1 Outpatient Department F/F 6 Hatiara Road Baguiati, Jyangra, Rajarhat, Kolkata, West Bengal 700159, India |
|
|
Primary Sponsor
|
| Name |
Diabetes and Allergy Asthma Therapeutics Specialty Clinic |
| Address |
Room No 1 Outpatient Department F/F 6 Hatiara Road Baguiati, Jyangra, Rajarhat, Kolkata, West Bengal 700159, India
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Rohan Tripathi |
Diabetes and Allergy Asthma Therapeutics Clinic |
Room No 1 Outpatient Department F/F 6 Hatiara Road Baguiati, Jyangra, Rajarhat, Kolkata, West Bengal 700159, India Kolkata WEST BENGAL |
9748843499
trohan747@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee, Allergy and Asthma Research Centre, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Apparently Healthy Elderly individual
Willingness to participate and provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Individuals unwilling or unable to provide informed consent
Any condition that, in the investigator’s opinion, precludes safe autonomic testing
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ewing’s Battery Tests
Parasympathetic (Cardiovagal)
Resting
Deep breathing
Response to standing (30:15)
Valsalva maneuver
Short-term HRV
Sympathetic (Adrenergic)
Postural hypotension (BP response)
Sustained hand grip
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
20/04/2026 |
| 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="6" 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
|
Cardiac autonomic function plays a critical role in cardiovascular regulation and overall physiological homeostasis. Establishing normative autonomic function parameters in healthy adults is essential for improving clinical interpretation of autonomic assessments and for creating reference datasets applicable to Indian populations. Despite the growing relevance of autonomic dysfunction in cardiology, neurology, endocrinology, and geriatric medicine, there is a lack of standardized, easily deployable tools capable of capturing autonomic parameters in routine clinical and research settings. Existing approaches are often infrastructure-intensive, time-consuming, and not suited for scalable data generation. NIBRA-CS® (Non-Invasive Baro Reflex Assessment – Combined System) is a non-invasive, validated, CDSCO-certified diagnostic device designed to assess cardiovascular autonomic function through standardized physiological measurements. This study is designed to evaluate cardiac autonomic function parameters in Otherwise Healthy Elderly adult volunteers, thereby generating baseline autonomic data and assessing feasibility in a real-world research environment. |