| 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
|
|
|
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
|
|
|
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. |