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CTRI Number  CTRI/2025/05/087463 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Clinical Testing of a New Diagnostic Device 
Scientific Title of Study   Clinical Validation of a Novel Compound Diagnostic Unit, NIBRA-CS for Assessment of Autonomic Neuro-Function Integrity 
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 Pvt Ltd, Kolkata 
Address  Inovocare Healthsoft Solutions Pvt Ltd, Kolkata 377, Purbalok Main Rd, Purbalok, Mukundapur, Kolkata, West Bengal 700099
Inovocare Healthsoft Solutions Pvt Ltd, Kolkata 377, Purbalok Main Rd, Purbalok, Mukundapur, Kolkata, West Bengal 700099
Kolkata
WEST BENGAL
700099
India 
Phone  9748843499  
Fax    
Email  trohan747@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shatavisa Mukherjee 
Designation  PG Student 
Affiliation  School of Tropical Medicine 
Address  Dept of Clinical Pharmacology, School of Tropical Medicine 108 C R Avenue Kolkata - 700073
Dept of Clinical Pharmacology, School of Tropical Medicine 108 C R Avenue Kolkata - 700073
Kolkata
WEST BENGAL
700073
India 
Phone  9830529192  
Fax    
Email  shatavisa100@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shatavisa Mukherjee 
Designation  PG Student 
Affiliation  School of Tropical Medicine 
Address  Dept of Clinical Pharmacology, School of Tropical Medicine 108 C R Avenue Kolkata - 700073
Dept of Clinical Pharmacology, School of Tropical Medicine 108 C R Avenue Kolkata - 700073
Kolkata
WEST BENGAL
700073
India 
Phone  9830529192  
Fax    
Email  shatavisa100@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Department of Science and Technology 
Address  Department of Science and Technology Government of India, New Delhi. 117486 
Type of Sponsor  Government funding agency 
 
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 
Dr Rohan Tripathi  Inovocare Healthsoft Solutions Pvt Ltd, Kolkata  Room No 1, Ground Floor, Inovocare Healthsoft Solutions Pvt Ltd, Kolkata 377, Purbalok Main Rd, Purbalok, Mukundapur, Kolkata, West Bengal 700099
Kolkata
WEST BENGAL 		 9748843499

trohan747@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committe - AARC Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Asymptomatic 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Device KODYSCAN  Commonly used device, “KODYSCAN” of Kody Medical Electronics Private Limited (Duration - 30 mins) 
Intervention  NIBRA CS  Test Device Non-Invasive Baro-Reflex Assessment – Combined System (Duration - 30 mins) 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy (asymptomatic) individuals of age between
16 and 65 years and of both gender residing in an urban community of Kolkata 
 
ExclusionCriteria 
Details  Those who deemed physically unfit by the investigators to undergo autonomic function tests  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparing two data sets using Bland-Altman Plot  Single 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for completing the screening  Baseline 
Ease of Operability  Baseline 
 
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)   09/06/2025 
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="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [trohan747@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A simple, portable, independent and stand-alone system with minimal infrastructural requirement device, called Non-Invasive Baro-Reflex Assessment – Combined System (NIBRA-CS™) has been developed. Preliminary validation of the prototype has been done against a similar, commonly used device, “KODYSCAN” of Kody Medical Electronics Private Limited. The present study aims to validate this NIBRA-CS™, against an existing device (KODYSCAN) for analysis of autonomic neurofunction based on a combination of Ewing’s battery of tests and short-term heart rate variability.

 
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