| CTRI Number |
CTRI/2023/04/051321 [Registered on: 05/04/2023] Trial Registered Prospectively |
| Last Modified On: |
28/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Hemoglobinopathies in Microcytic Hypochromic Anemia Cases by High Performance Liquid Chromatography |
|
Scientific Title of Study
|
Evaluation of Hemoglobinopathies in Cases of Microcytic Hypochromic Anemia by High Performance Liquid Chromatography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saumya Bindlish |
| Designation |
PG Resident |
| Affiliation |
Bhagat Phool Singh Govt.Medical college for Women |
| Address |
Department of Pathology, Bhagat Phool Singh Government Medical college for Women, Khanpur Kalan, Sonepat Department of Pathology, Bhagat Phool Singh Government Medical college for Women, Khanpur Kalan, Sonepat Sonipat HARYANA 131305 India |
| Phone |
7060616094 |
| Fax |
|
| Email |
Saum.bindlish@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ruchi Agarwal |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Department of Pathology, Bhagat Phool Singh Government Medical college for Women, Khanpur Kalan, Sonepat Department of Pathology, Bhagat Phool Singh Government Medical college for Women, Khanpur Kalan, Sonepat Sonipat HARYANA 131305 India |
| Phone |
9215340907 |
| Fax |
|
| Email |
Pg.ruchi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saumya Bindlish |
| Designation |
PG Resident |
| Affiliation |
Bhagat Phool Singh Govt.Medical college for Women |
| Address |
Department of Pathology, Bhagat Phool Singh Government Medical college for Women, Khanpur Kalan, Sonepat Department of Pathology, Bhagat Phool Singh Government Medical college for Women, Khanpur Kalan, Sonepat Sonipat HARYANA 131305 India |
| Phone |
7060616094 |
| Fax |
|
| Email |
Saum.bindlish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh Govt. Medical College, Khanpur Kalan, Sonepat |
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Govt. Medical College, Khanpur Kalan, Sonepat |
| Address |
Bhagat Phool Singh Govt. Medical College, Khanpur Kalan, Sonepat |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumya Bindlish |
Bhagat Phool Singh Government Medical College for Women |
Department of Pathology, Bhagat Phool singh government medical college for women, Khanpur Kalan Sonipat HARYANA |
7060616094
Saum.bindlish@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: D582||Other hemoglobinopathies, (2) ICD-10 Condition: D578||Other sickle-cell disorders, (3) ICD-10 Condition: D569||Thalassemia, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Blood samples of patients with microcytic hypochromic anemia received for detection of hemoglobinopathies. |
|
| ExclusionCriteria |
| Details |
Patients with history of blood transfusion within past three months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the spectrum of hemoglobinopathies by High Performance Liquid Chromatography in patients with microcytic hypochromic anemia. |
6months to 1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To estimate the spectrum of various hemoglobinopathies in cases of microcytic hypochromic anemia.
2. To correlate the hematological findings with various hemoglobinopathies. |
6months to 1 year |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
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)
|
08/04/2023 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anemia remains a widespread public health problem with major consequences for human health as well as social and economic development. Although estimates of the prevalence of anemia vary widely and accurate data are often lacking, it can be assumed that significant proportions of young children and women of childbearing age are anaemic. Nutritional deficiency such as iron, vit B12 and folic acid constitutes most common causes of anemia. Due to higher prevalence of anemia and because of varied number of causes leading to anemia, RBC indices and morphology in peripheral blood are crucial for deciding further investigation to reach a proper diagnosis.Hemoglobinopathies are the most common inherited disorders worldwide. These hereditary disorders are major public health problem in many parts of the world including India. Hemoglobinopathies are the group of genetic disorders of hemoglobin in which there is a quantitative or qualitative abnormal production, or in the structure of hemoglobin molecule. Basic investigations for detection of hemoglobin variants include red cell indices, hemoglobin pattern analysis by High Performance Liquid Chromatography (HPLC), electrophoresis and molecular studies. HPLC is intended for the percent determination of hemoglobins A2, F, A1C and for detection of abnormal hemoglobins in human whole blood using ion- exchange chromatography. HPLC offers a reliable tool for early detection of hemoglobin variants thereby aiding in prevention and management of various hemoglobinopathies.5 This study is being done for evaluation of hemoglobinopathies in cases of microcytic hypochromic anemia by HPLC. All peripheral smears, complete blood count and HPLC findings will be interpreted initially by postgraduate student, later by supervisor and co-supervisors as per standard textbook and literature. The collected data will be entered into Microsoft Excel spreadsheet. The Mean + SD will be calculated for quantitative data. Percentage and proportion will be calculated for qualitative data. Chi-square test and other appropriate test will be used to find out association between categorical variables. Using SPSS (ver 20) Software, p value < 0.05 will be considered as statistically significant. |