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CTRI Number  CTRI/2025/06/089075 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Device]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical Performance Testing of SYSTEM AND METHOD FOR REAL TIME VITAL SIGN MONITORING  
Scientific Title of Study   SYSTEM AND METHOD FOR REAL TIME VITAL SIGN MONITORING USING IOT 
Trial Acronym  SMRDVSM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAbhinam Patel 
Designation  Principal Investigator 
Affiliation  Parul Institute of Medical Sciences & Research 
Address  Parul Sevashram Hospital, Parul University, P.O. Limda, Tal. Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9898149434  
Fax    
Email  abhinam.patel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jignesh Patel 
Designation  Clinical Research 
Affiliation  Parul Sevashram Hospital 
Address  Parul Sevashram Hospital, Parul University, P.O. Limda, Tal. Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9978067027  
Fax    
Email  cr.psh@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Khushi Shah 
Designation  student 
Affiliation  Parul Institute of Engineering and Technology (PIET) 
Address  P.O. Limda, Tal., Waghodia, Vadodara, Gujarat 391760
Parul Institute of Engineering and Technology (PIET) is located at P.O. Limda, Ta. Waghodia, Vadodara, Gujarat, India,
Vadodara
GUJARAT
391760
India 
Phone  9909745266  
Fax    
Email  khushi210104@gmail.com   
 
Source of Monetary or Material Support  
Parul University 
 
Primary Sponsor  
Name  Parul University  
Address  Parul Sevashram Hospital, Parul University, P.O. Limda, Tal. Waghodia, Vadodara, Gujarat, India, 391760 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Parul Institute of engineering and tec  Parul University, P.O. Limda, Tal. Waghodia, Vadodara, Gujarat 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhinam H Patel   parul sevashram hospital   Room 314 department of medicine PO Limda, Taluka Waghodia Vadodara Gujarat 391760
Vadodara
GUJARAT 		 9898149434

abhinam.patel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
parul university institute ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J312||Chronic pharyngitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BPL Smart Oxy Finger Tip Pulse Oximeter, Omron HEM 8712 Blood Pressure Monitor, Omron Digital Thermometer MC 246   Device Manager to Blood Pressure, SPO2, HeartRate 
Intervention  VSIGNS  Device Manager to BloodPressure SPO2,HeartRate,Body Temperature  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Any healthy subject or patient who voluntarily ready to undergo heart rate, systolic blood pressure, diastolic blood pressure, SPO2, body temperature
2. Any volunteer who gives informed consent to participate in this study 
 
ExclusionCriteria 
Details  1. Critically ill and clinically unstable patient who may not be comfortable to undergo the study process
2. Patient having any psychological illness which may compromise the patient’s compliance / co-operation for the study process 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart rate
Systolic blood pressure
Diastolic blood pressure
SPO2
Body temperature 		 at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Safety   at baseline 
User Experience   at baseline 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) 20/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/05/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

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

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response (Others) - 

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

Efforts will be made to different variety of subjects having following characteristics and diseases patterns; however, it is not compulsory to cover all following characteristics and diseases patterns.

 

· Healthy subject

· Patients with abnormal heart rate, blood pressures, SPO2, body temperature

· Patients with hard skin at finger tip

· Patients with soft skin at finger tip

· Patients with hard skin at finger tip

· Patients with obesity having swollen or fatty finger tip

Patients with thin finger tip

150 subjects are planned to be randomized into 6 sequences of 3 groups equally.

- TRP

- TPR

- RTP

- RPT

- PTR

- PRT

 

Test Product Group

(T)

Reference Products Group

(R)

Reference Procedure Group

(P)

Following to be measured using Test Product

ü Heart rate

ü Systolic blood pressure

ü Diastolic blood pressure

ü SPO2

ü Body temperature

Following to be measured using Reference Products

ü Heart rate

ü Systolic blood pressure

ü Diastolic blood pressure

ü SPO2

ü Body temperature

Following to be measured using Reference Procedure – Sphygmomanometry using Mercury Sphygmomanometer

ü Heart rate

ü Systolic blood pressure

ü Diastolic blood pressure

· Subject will undergo screening based on the available medical records and will be enrolled in the study if the subject meets required criteria.

There is no likely to have any adverse event, but if happen, all adverse event will be captured and its association with use of ECG machine will be evaluated as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) definition of definite, probable, possible or unlikely.

 
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