| CTRI Number |
CTRI/2024/11/076624 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study on Reticulocyte Hemoglobin Equivalent in Anaemia |
|
Scientific Title of Study
|
A Study on Reticulocyte Hemoglobin Equivalent in Evaluation of Anaemia |
| 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 Sunita Aggarwal |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 124 Department of Medicine B L Taneja block Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968281414 |
| Fax |
|
| Email |
drsunita.mamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lochan Rajeev Gejji |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward no 32 Department of Medicine Maulana Azad Medical College New Delhi
DELHI
110002
India |
| Phone |
9606520057 |
| Fax |
|
| Email |
lgejji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lochan Rajeev Gejji |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward no 32 Department of Medicine Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9606520057 |
| Fax |
|
| Email |
lgejji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical College and Associated Lok Nayak GNEC and GIPMER Hospitals New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
Maulana Azad Medical College Bahadur shah zafar Marg New Delhi 110002 |
| Type of Sponsor |
Government 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 Lochan Rajeev Gejji |
Maulana Azad Medical College And Associated Lok nayak GNEC and GIPMER Hospitals New Delhi 110002 |
Ward no 32 Department of medicine Maulana Azad Medical college Bahadur shah Zafar Marg New Delhi 110002
New Delhi
DELHI |
9606520057
lgejji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (2) ICD-10 Condition: D519||Vitamin B12 deficiency anemia, unspecified, (3) ICD-10 Condition: D529||Folate deficiency anemia, unspecified, (4) ICD-10 Condition: D559||Anemia due to enzyme disorder, unspecified, (5) ICD-10 Condition: D62||Acute posthemorrhagic anemia, (6) ICD-10 Condition: D631||Anemia in chronic kidney disease, (7) ICD-10 Condition: D638||Anemia in other chronic diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reticulocyte Hemoglobin Equivalent level in blood |
To look for value of Reticulocyte Hemoglobin equivalent in patients diagnosed with anaemia by drawing blood in EDTA vial and sample is analysed by a routine Haematology Analyser in 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients Diagnosed with Anaemia according to World Health Organisation Definition of Anaemia for Males And Females |
|
| ExclusionCriteria |
| Details |
1. All Patients on Iron and Epo Therapy
2. All Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Reticulocyte Hemoglobin Equivalent in Anaemia |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Compare Reticulocyte Hemoglobin Equivalent value Equivalent with Traditional Parameters such as Serum Iron Serum TIBC & RBC indices
2. To differentiate between Anaemia of chronic disease & Iron Deficiency Anaemia on The Basis of Reticulocyte Hemoglobin Equivalent |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/11/2024 |
| 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 - NO
|
|
Brief Summary
|
This study is a Cross sectional Observational Study on Reticulocyte Hemoglobin Equivalent in Evaluation of Anaemia for 1 year (According to WHO definition of anaemia) visiting ward no 32 Maulana Azad Medical College and Associated Lok Nayak GNEC and GIPMER Hospitals New Delhi India. The Primary Outcome is to evaluate Reticulocyte Hemoglobin Equivalent in Anaemia. The Secondary outcomes are : 1. to Compare Reticulocyte Hemoglobin Equivalent with other Traditional Parameters such as Serum Iron , Serum TIBC and RBC indices. 2. To Differentiate between Anaemia of Chronic disease and Iron deficiency Anaemia on the basis of Reticulocyte Hemoglobin Equivalent value. |