| CTRI Number |
CTRI/2025/03/082714 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Observational Study In Tertiary Care Center Of Clinico Etiological And Hematological Profile In Patients With Chronic Liver Disease. |
|
Scientific Title of Study
|
Clinico Etiological And Hematological Profile In Patients With Chronic Liver d
Disease: An Observational Study In Tertiary Care Center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kinjal Patel |
| Designation |
Junior resident |
| Affiliation |
Dr D Y Patil Medical College,Navi Mumbai |
| Address |
Department of General Medicine Dr D Y Patil Medical College ,Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9167204819 |
| Fax |
|
| Email |
kinjal0498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Patil |
| Designation |
Professor |
| Affiliation |
D y patil medical college |
| Address |
Department of General Medicine Dr D Y Patil Medical College ,Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9821027742 |
| Fax |
|
| Email |
smita.patil@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kinjal Patel |
| Designation |
Junior resident |
| Affiliation |
D y patil medical college |
| Address |
Department of General Medicine Dr D Y Patil Medical College ,Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9167204819 |
| Fax |
|
| Email |
kinjal0498@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D Y Patil Medical College and Hospital,Nerul ,Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Kinjal Patel |
| Address |
Junior Resident Department of General Medicine ,Dr D Y Patil Medical College,Navi Mumbai -400706 |
| Type of Sponsor |
Other [Primary investigator ] |
|
|
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 Kinjal Patel |
Dr D Y Patil Hospital |
OPD-1 (General Medicine OPD ) ,OPD -8 (GastrologyOPD ),Female Medicine Ward ,Male Medicine ward ,IIntensive Care Unit ,Dr D Y Patil Hospital Nerul,Navi Mumbai ,Maharashtra 400706
Thane
MAHARASHTRA |
9167204819
kinjal0498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research, Dr DY Patil Medical College,Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with chronic liver disease
Patients giving consent for the study
Patients of both genders and above the age of 18 |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Patient less than 18 years of age |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hemoglobin
Platelet count
Liver texture
Oesophageal varices |
Baseline
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Co relation between clinical hematological biochemical & etiological factors in chronic liver disease
LFT
PT INR
HHH
Scopy findings |
Baseline
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/03/2025 |
| 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 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)?
|
|
Brief Summary
|
It is an observational study Clinico etiological and hematological study of chronic liver disease in tertiary care centre and their outcomes and inter relationships |