| CTRI Number |
CTRI/2023/06/053978 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Study of ANAEMIA in Children and women of reproductive age |
|
Scientific Title of Study
|
Evaluation of Nutritional Anaemia in children as well as females in reproductive age group at tertiary care centre in Shahjahanpur, U.P |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIWANI GUPTA |
| Designation |
Post graduate student |
| Affiliation |
Varun Arjun Medical College and Rohilkhand hospital |
| Address |
Room number 3, Department of Pathology
Varun Arjun Medical College and Rohilkhand Hospital
Banthra
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9919013248 |
| Fax |
|
| Email |
shiwanigupta.511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A. K. Bansal |
| Designation |
Professor and Head of Department |
| Affiliation |
Varun Arjun Medical College and Rohilkhand hospital |
| Address |
Room number 3, Department of Pathology Varun Arjun Medical College and Rohilkhand Hospital
Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8887547243 |
| Fax |
|
| Email |
Pathopathbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIWANI GUPTA |
| Designation |
PG JR |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Room number 3, Department of Pathology Varun Arjun Medical College and Rohilkhand Hospital
Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9919013248 |
| Fax |
|
| Email |
shiwanigupta.511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand hospital, Banthara, Shahjahanpur, U.P |
|
|
Primary Sponsor
|
| Name |
shiwani gupta |
| Address |
Room number 3, Department of Pathology Varun Arjun Medical College and Rohilkhand Hospital
Banthara |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Shiwani Gupta |
Varun Arjun Medical College and Rohilkhand Hospital |
Room number 157, Department of Pathology, Banthara
Shahjahanpur
UTTAR PRADESH |
9919013248
shiwanigupta.511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, VAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1.All inpatients and outpatients’ women in the reproductive age group and children having haemoglobin less than 11gm/dl
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1.Patients having history of taking supplemental iron during previous years
2.History of blood transfusion
3.Family history of anaemia
4.History of receiving oral contraceptive pills (OCPS) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
|  To evaluate the status of nutritional anaemia in women of reproductive age group and children . |
ONE YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
 To know the proportion of nutritional anaemia in moderate to severe anaemic patients.
|
ONE 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)
|
19/07/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study was to evaluate the clinical and haematological profile with respect to nutritional anaemia in women of reproductive age group & children in a recently established tertiary health care center. This will help in the proper diagnosis and appropriate treatment of nutritional anaemia in women of reproductive age group and children. |