| CTRI Number |
CTRI/2025/07/090128 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic accuracy study |
| Study Design |
Other |
|
Public Title of Study
|
Diagnostic Accuracy of EzeCheck,a non invasive Hemoglobin estimation equipment. |
|
Scientific Title of Study
|
Diagnostic Accuracy of a Non-invasive Point of Care Hemoglobin Estimation Device (EzeCheck) Compared with Hematology Analyzer for Anaemia Assessment: A Community based Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Palkar |
| Designation |
Professor Community Medicine |
| Affiliation |
Bharati Vidyapeeth DU Medical College Pune |
| Address |
Department of Community Medicine, Bharati Vidyapeeth DU Medical College & Hospital
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA
411043
India |
| Phone |
9881008717 |
| Fax |
|
| Email |
palkarsh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Palkar |
| Designation |
Professor Community Medicine |
| Affiliation |
Bharati Vidyapeeth DU Medical College Pune |
| Address |
Department of Community Medicine, Bharati Vidyapeeth DU Medical College & Hospital
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA
411043
India |
| Phone |
9881008717 |
| Fax |
|
| Email |
palkarsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Palkar |
| Designation |
Professor Community Medicine |
| Affiliation |
Bharati Vidyapeeth DU Medical College Pune |
| Address |
Department of Community Medicine, Bharati Vidyapeeth DU Medical College & Hospital
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA
411043
India |
| Phone |
9881008717 |
| Fax |
|
| Email |
palkarsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth DU Medical College |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth DU Medical College |
| Address |
Pune Satara Road
Dhanakawadi
Pune Maharashtra
India
Pin code 411043 |
| Type of Sponsor |
Private medical college |
|
|
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 Sonali Palkar |
Bharati Vidyapeeth DU Medical College Hospital And Research Center |
Clinical Research Unit
Pediatric OPD
Bharati Hospital And Research Centre
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA |
9881008717
palkarsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (Deemed to be University) Medical College Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Whether healthy or having any disease, both will be included. Comorbidities will be noted. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Children from the age of 4 to 17 years and adults from 18 years and above residing in the study area. |
|
| ExclusionCriteria |
| Details |
Application of henna or injury to fingers of left hand |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and Specificity of EzeCheck equipment for detection of Anaemia |
Cross sectional study so will be done at baseline visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pearson correlation between EzeCheck and auto-analyser haemoglobin values |
Cross sectional study so will be done at baseline visit |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
16/07/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [palkarsh@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Anemia is a global public health problem faced especially by people from low and middle-income countries including India. It is prevalent across all age groups from childhood to adulthood. The Government of India is committed to combating anemia. Anemia Mukt Bharat Program under POSHAN Abhiyan uses the 6X6X6 strategy and aims to reduce the prevalence of anemia among various groups. Addressing anemia requires a multifaceted approach encompassing improved nutrition, iron supplementation, and, critically, effective diagnostic strategies.
Clinical diagnosis of anemia is subjective and depends upon various factors like complexion of patient, availability of natural/good light and clinical expertise of the health care worker. While laboratory-based methods, such as complete blood counts using hematology analyzers, are considered the gold standard for hemoglobin estimation, their widespread use is often hindered by logistical constraints, particularly in resource-limited settings and remote areas. The mass screening of the targeted population at least once in six months or during the school health check-up of adolescents will help identify the patients with anemia and they can be treated with an appropriate dose and duration. The current program uses invasive digital hemoglobinometers but only for a limited population of pregnant women and those with suspected anemia. EzeCheck is another point-of-care, non-invasive device that eliminates needles and blood draws. These innovative devices prioritise user-friendliness, portability, affordability in low-resource environments, and reduced reporting time, ultimately enhancing patient satisfaction. Validated by ICMR, this device can be used after the age of 4 years and shows moderate agreement with a haematological auto-analyser. Of 1457 participants, the study had only 16 children of 4-11 years and 79 from 12 to 18 years. There was no specific representation of pregnant women. This noninvasive point-of-care device has the potential to be used for mass screening. However, rigorous evaluation of its diagnostic accuracy in diverse population subgroups, particularly within the Indian context, is essential before widespread implementation can be considered. So, we plan to evaluate the diagnostic accuracy of the EzeCheck device in the community, especially in the target groups identified under Anemia Mukta Bharat.
|