| CTRI Number |
CTRI/2024/09/073232 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Paired design diagnostic accuracy study |
| Study Design |
Other |
|
Public Title of Study
|
Development of non -invasive device for screening of anaemia |
|
Scientific Title of Study
|
Development of Non-Invasive Screening of Haemoglobin for Anaemia Device (NISHAD) as a Point of Care Test: A pilot 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 Arunita Tushar Jagzape |
| Designation |
Assistant Professor, Physiology |
| Affiliation |
AIIMS raipur |
| Address |
Department of Physiology
AIIMS Raipur
GE Road, Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9423616562 |
| Fax |
|
| Email |
arunitajagzape@aiimsraipur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunita Tushar Jagzape |
| Designation |
Assistant Professor, Physiology |
| Affiliation |
AIIMS raipur |
| Address |
Department of Physiology
AIIMS Raipur
GE Road, Tatibandh
CHHATTISGARH
492099
India |
| Phone |
9423616562 |
| Fax |
|
| Email |
arunitajagzape@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunita Tushar Jagzape |
| Designation |
Assistant Professor, Physiology |
| Affiliation |
AIIMS raipur |
| Address |
Department of Physiology
AIIMS Raipur
GE Road, Tatibandh
CHHATTISGARH
492099
India |
| Phone |
9423616562 |
| Fax |
|
| Email |
arunitajagzape@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Raipur
G E Road, Tatibandh,
Raipur, Chhattisgarh, India
Pincode 492099 |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
AIIMS Raipur
GE Road, Tatibandh
Raipur, Chhattisgarh, India
Pincode 492099 |
| Type of Sponsor |
Other [Central Government Institute Medical college and hospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preetam N Wasnik |
AIIMS Raipur |
OPD and IPD
Department of Medicine
Raipur
CHHATTISGARH |
9823706618
pnwasnik@aiimsraipur.edu.in |
| Dr Tushar Jagzape |
AIIMS Raipur |
OPD and IPD
Department of Pediatrics
Raipur
CHHATTISGARH |
9421783796
tusharjagzape@aiimsraipur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NIL |
| Comparator Agent |
Nil |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
All patients in the age group of 2 to 59 years who have been advised Complete Blood Count |
|
| ExclusionCriteria |
| Details |
Critically ill patients
Patients with jaundice
Patients of sickle cell disease or trait
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Value of Hb (by device and CBC) |
2 months, 4 months, 6 months, 8 months, 10 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Corpuscular Volume |
1 year |
| Sensitivity |
1 year |
| Specificity |
1 year |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="520"
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)
|
16/09/2024 |
| 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="1"
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 - 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
Response - Statistical Analysis Plan
Response (Others) - Study report
- Who will be able to view these files?
Response (Others) - It will be shared as study report to Institute Research Committee and as publication in journals
- 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 (Others) - As submission of study report to Institute Research Committee and as publication in journal
- For how long will this data be available start date provided 01-10-2026 and end date provided 01-10-2029?
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
|
This study will be undertaken to develop a device for non-invasive screening for anaemia. A prototype shall be developed. In the OPD/IPD, patients who have been advised Complete Blood Count (CBC) will be explained about the study. If they consent to participate, primary demographic data will be recorded and every subject (anaemic or normal) will be asked to insert their index finger in the area provided in the prototype device and keep it for few seconds. The value displayed shall be compared with the CBC reports. Data will be analysed using paired t test and significance level of p< .05 shall be considered. ROC curve will be constructed. Area under curve, sensitivity, specificity, positive predictive value and negative predictive value shall be computed. Categorical data shall be analysed using chi square test.
|