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CTRI Number  CTRI/2024/04/066473 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessing the efficacy of RBC histogram peripheral smear indices for the diagnosis of anemia.  
Scientific Title of Study   Assessing the efficacy of RBC histogram and indices on peripheral smear for the detection of anemia at AVBRH (Sawangi) Wardha Maharashtra. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Dinesh Rajurkar 
Designation  Post Graduate Medical Laboratory Technology 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept. of Pathology,Jawaharlal Nehru Medical College, DMIHER,Sawangi,Wardha 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9284108484  
Fax    
Email  vaishnvirajurkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ketki Wajpeyi  
Designation  Senior Resident Dept. of Pathology 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept. of Pathology,2nd floor,Jawaharlal Nehru Medical College, DMIHER,Sawangi,Wardha 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8888985306  
Fax    
Email  wajpeyiketki9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vaishnavi Dinesh Rajurkar 
Designation  Post Graduate Medical Laboratory Technology 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept. of Pathology,Jawaharlal Nehru Medical College, DMIHER,Sawangi,Wardha 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9284108484  
Fax    
Email  vaishnvirajurkar@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Sawangi,Wardha 442001, Maharashtra, India 
 
Primary Sponsor  
Name  Vaishnavi Dinesh Rajurkar 
Address  Datta Meghe Institute of Higher Education and Research Sawangi,Wardha 442001, Maharashtra, India 
Type of Sponsor  Private 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 Ketki Wajpeyi  Acharya Vinoba Bhave Rural Hospital   Central Laboratory, Acharya Vinoba Bhave Rural Hospital Sawangi Wardha.
Wardha
MAHARASHTRA 
8888985306

wajpeyiketki9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D599||Acquired hemolytic anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient with anemia
Patient of Indian origin
Patient of age 11-65 years old

 
 
ExclusionCriteria 
Details  Patient diagnosed with leukemia/ lymphoma.
Patient less than 11 years of age or more than 65 years of age.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
However, a complete blood count (CBC), which reports the amount of haemoglobin in the blood, under a microscope, we will look for any abnormalities in red blood cells, which are visible in anemia patients is always the gold standard for diagnosing anemia.

 
Assessment after 11 months

 
 
Secondary Outcome  
Outcome  TimePoints 
No secondary outcome  Not applicable 
 
Target Sample Size   Total Sample Size="314"
Sample Size from India="314" 
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)   01/06/2024 
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  

Abstract:

Background: Anemia is a disorder in which there is a decrease in the usual number of red blood cells in the blood. Reduced levels of hemoglobin, red blood cell counts, and the blood’s ability to carry oxygen are among the signs and symptoms of anemia. The condition worsens when the body’s red blood cells are unable to supply the tissues with enough oxygen. Anemia is diagnosed with PBS, and microscopic examination of blood smears can reveal crucial information about alterations in red blood cell composition and size as well as the existence of inclusion bodies. The red blood cell indices can reveal details regarding the aetiology of an individual’s anemia. Hemoglobin and red blood cell measurements are used to compute the red blood cell indices. for an accurate assessment of anemia Peripheral smear examination, red cell indices, and the RBC histogram are crucial.

Method: Possible candidates will be chosen on the basis of their primary worries, such as symptomatic anemia or relatives with it.
Following it, a peripheral blood analysis and complete blood count will be conducted.
A sample of blood will be collected while the patient is seated comfortably and in an aseptic environment. For CBC and peripheral smear testing, 2 ml of blood will be collected from an ordinary central cubital vein and placed in an EDTA tube.

Results: According to results, we will compare the Complete blood count and the Peripheral blood film approach to determine which is best.

Conclusion: The study’s findings show that RBC graphic examination is superior than RBC indices obtained from peripheral smears for diagnosing anemia.
When evaluating individuals who can have anemia, its greater reactivity and similar specific make it an essential tool in clinical practice.
Using RBC histogram research in regular hematology practice may lead to more exact diagnoses and better anemic patient care.
More study is needed to validate the results and examine the possible benefits of combining techniques to improve diagnostic efficacy.

 
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