| 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
|
|
|
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
|
|
|
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. |