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CTRI Number  CTRI/2024/07/071140 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Rate of Hepatitis C virus in blood donors by ABO blood group at JNMC, sawangi, wardha 
Scientific Title of Study   Incidence of HCV in volunteery blood donors of ABO blood group system in blood center jawaharlal medical College sawangi Meghe, wardha 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Aboli Awari  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aboli Awari 
Designation  Student 
Affiliation  Datta Meghe Institute Of Higher Education and Research 
Address  Department of Pathology, 2nd Floor Jawaharlal Nehru Medical College DMIHER, Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8830271425  
Fax    
Email  abhisawari6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Agrawal 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Pathology, 2nd Floor Jawaharlal Nehru Medical College DMIHER, Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9850309278  
Fax    
Email  dranilagrawal.456@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Agrawal 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Pathology, 2nd Floor Jawaharlal Nehru Medical College DMIHER, Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9850309278  
Fax    
Email  dranilagrawal.456@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education Research 
Address  Sawangi Meghe Wardha, 442001  
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 
Aboli Awari  Jawaharlal Nehru Medical College   Blood Bank, E-Block Ground floor, Department of Pathology, Jawaharlal Nehru Medical College, Sawangi, wardha
Wardha
MAHARASHTRA 
8830271425

abisawari6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Blood Donors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  All the Voluntary blood donors donating in AVBRH JNMC blood centre tested for HCV From October 2022 to July 2024  
 
ExclusionCriteria 
Details  People who are not compatible for blood donation due to various reasons such as age, weight, Hemoglobin, disease, medication, etc 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The present study attempt to suggest patients to take a treatment of HCV  1 year, 10 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="5000" 
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)   01/08/2024 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

According to the World Health Organisation, complications from hepatitis killed 23,720 persons in Pakistan in 2016. ABO blood group variations affected how sensitive people were to various illnesses. People with blood types A and AB, for example, were more likely to experience severe malaria, whereas people with blood type O had higher levels of resistance to the protozoan agent.With almost half of the patients receiving neither treatment nor diagnosis,The hepatitis C virus continues to pose a major threat to public health. Chronic HCV is mainly responsible for cirrhosis, fibrosis, hepatocellular cancer, and other hepatic morbidities. On the basis of their ages, the study participants will be split into four groups. Patients in the first group ranged in age from 17 to 25 years old (52), while those in the second, third, and fourth groups ranged from 26 to 34 years old (92), 35 to 43 years old (42), and 44 years and older (14) respectively. Because average viral load in females was higher than in men, HCV Viremia had a more serious effect on females than on males. The experiences of HCV patients must be improved through increased societal awareness and gender-sensitive healthcare. An estimated 130 million people worldwide have the hepatitis C virus (HCV), the majority of whom are chronic carriers. People who have HCV infection are at risk for cirrhosis, primary hepatocellular carcinoma (HCC), and serving as a reservoir for the spread of the infection to others. According to estimates, cirrhosis affects 27% and HCC affects 25% of the global population, respectively. There is a good chance that HCV infection has been widespread for centuries numerous populations.

 
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