| CTRI Number |
CTRI/2025/05/086874 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Wearable device to measure body signals and find Health Problems Early |
|
Scientific Title of Study
|
Computational Approach for Predictive Analysis of Vital Signs Collected using a Suitable Wearable Device |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savithri Prabhu |
| Designation |
Research Scholar |
| Affiliation |
Manipal Institute of Technology, Manipal |
| Address |
Department of Biomedical Engineering, Manipal Institute of Technology, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
07975836586 |
| Fax |
|
| Email |
savithri.mitmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Muralidhar Bairy |
| Designation |
professor(Guide) |
| Affiliation |
Manipal Institute of Technology, Manipal |
| Address |
Department of Biomedical Engineering, Manipal Institute of Technology, Manipal,576104,Udupi,India
Udupi
KARNATAKA
576104
India |
| Phone |
9845248317 |
| Fax |
|
| Email |
gm.bairy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Savithri Prabhu |
| Designation |
Research Scholar |
| Affiliation |
Manipal Institute of Technology, Manipal |
| Address |
Department of Biomedical Engineering, Manipal Institute of Technology, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
07975836586 |
| Fax |
|
| Email |
savithri.mitmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education,Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education,Manipal |
| Address |
Manipal Academy of Higher Education (MAHE)
University Building, Manipal.edu
Madhav Nagar, Manipal – 576104
Udupi District, Karnataka, India |
| Type of Sponsor |
Other [Academic and Research Institution] |
|
|
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 Anupa Appu Shetty |
Kasturba Medical College Manipal |
Manipal 576104,Udupi,Karnataka
Udupi
KARNATAKA |
9740589560
anupa.shetty@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
Healthy individuals and mild infectious Persons |
|
| ExclusionCriteria |
| Details |
Pregnant Women, Children, Fetuses, Physically challenged, Terminally ill, Seriously ill |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The system helps to acquire vital signs and do predictive analysis. |
The system helps to acquire vital signs and do predictive analysis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
02/08/2025 |
| 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="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
|
Ethical clearance is obtained. Data will be collected after getting permission from CTRI. |