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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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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    
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.
 
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