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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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