| CTRI Number |
CTRI/2022/08/044952 [Registered on: 26/08/2022] Trial Registered Prospectively |
| Last Modified On: |
22/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The efficacy of EzeCheck device for its use in the Gynecologic department. |
|
Scientific Title of Study
|
Noninvasive detection of Hemoglobin, bilirubin, oxygen saturation, creatinine and other basic healthcare parameter using EzeCheck device for across age groups. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nirmal Mohakud |
| Designation |
Associate Professor, Dept.of Pediatrics |
| Affiliation |
Kalinga Institute of Medical Science |
| Address |
Kalinga Institute of Medical Science, Department of Pediatrics, KIIT University, Room no.-30
Khordha
ORISSA
751024
India |
| Phone |
9437365233 |
| Fax |
|
| Email |
nirmal.mahakud@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirmal Mohakud |
| Designation |
Associate Professor, Dept.of Pediatrics |
| Affiliation |
Kalinga Institute of Medical Science |
| Address |
Kalinga Institute of Medical Science, Department of Pediatrics, KIIT University, Room no.-30
Khordha
ORISSA
751024
India |
| Phone |
9437365233 |
| Fax |
|
| Email |
nirmal.mahakud@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmal Mohakud |
| Designation |
Associate Professor, Dept.of Pediatrics |
| Affiliation |
Kalinga Institute of Medical Science |
| Address |
Kalinga Institute of Medical Science, Department of Pediatrics, KIIT University, Room no.-30
Khordha
ORISSA
751024
India |
| Phone |
9437365233 |
| Fax |
|
| Email |
nirmal.mahakud@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| EzeRx Health Tech Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Partha Pratim Das Mahapatra |
| Address |
Suite-825, DLF Cyber City, Patia, BBSR |
| Type of Sponsor |
Other [Med-tech Startup] |
|
|
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 Nirmal Mohakud |
KIMS |
Obstetrics & Gynaecology, Maternal Ward,1st floor, Old Building
Khordha
ORISSA |
9437365233
nirmal.mahakud@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (KIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All female patients who have undergone delivery and prescribed for the Hemoglobin test. |
|
| ExclusionCriteria |
| Details |
Applied Mehndi on finger tip or have any skin disease which can affect the upper dermal layer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the non-invasive device for determining the Hb levels. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the device in detecting post-partum anemia cases. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/09/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We want to determine the efficacy of the newly developed non-invasive device to determine the Haemoglobin levels in the female patients after the delivery , to check how accurately the device can detect the cases of post-partum anemia. |