| CTRI Number |
CTRI/2021/02/030877 [Registered on: 01/02/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of anaemia among school going Children |
|
Scientific Title of Study
|
STUDY OF PREVALENCE OF FAQR AL-DAM (ANAEMIA) AMONG SCHOOL GOING CHILDREN. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Safder Husain |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept. of Tahffuzi wa Samaji Tib, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya,Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
7000893055 |
| Fax |
|
| Email |
shjafry65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arish MK Sherwani |
| Designation |
professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept.of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya, Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9448794691 |
| Fax |
|
| Email |
arish_sherwani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Safder Husain |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept. of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya,Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9448794691 |
| Fax |
|
| Email |
shjafry65@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Magadi Main Road, Kottigepalya, Bengaluru-560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani medicine |
| Address |
National Institute Unani Medicine, Magadi Main Road, kottigepalya,Bengaluru-560091 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Safder Husain |
Government school of Bengaluru (Karnatka) |
Gov. School in Kottigepalya, Main Magadi Road, Bengaluru-560091
Bangalore
KARNATAKA |
7000893055
shjafry65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D539||Nutritional anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both sexes.
2.School going children of age group of 8 to 14 years.
3.3-8 grade school age children.
4.No history of major surgery.
|
|
| ExclusionCriteria |
| Details |
1.Below 8 and above 14 years of children.
2.Below 3rd grade and above 8th grade.
3.History of any surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of anaemic patients |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2021 |
| Date of Study Completion (India) |
03/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/04/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The main Aim of the study is to find out the prevalence of anaemia among school going children in Bengaluru, Karnataka. Anaemia refers to a state in which the level of haemoglobin in blood below 10g/dl as marked anaemia. Anaemia is a significant global problem. It is one of the major public health problems in school children and according to the World Health Organization 43% of the world’s children are parasitized. Procedure of the Investigation: Estimation of Hb% is done on school children by strip method with the drop of blood by finger prick. Hb% will be assessed to study the prevalence of anaemia. Anaemic children will be further examined for worm infestation by Stool routine microscopic test (for Ova & Cysts) in NIUM laboratory and these anaemics will be evaluated also for CBC, MCH, MCV and referred to community medicine OPD for the treatment of anaemia. |