| CTRI Number |
CTRI/2025/01/079454 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Cardiovascular profile in case of Non alcoholic fatty liver disease |
|
Scientific Title of Study
|
Cardiovascular profile of patients Diagnosed with Non alcoholic fatty liver Disease A Cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bindukumar Patel KT |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General medicine,Dr DY Patil Medical College,Navi Mumbai , Thane, Maharashtra -400706
INDIA
Thane
MAHARASHTRA
400706
India |
| Phone |
8277091799 |
| Fax |
|
| Email |
ktbindukumar18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arundhati Barua |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General medicine,Dr DY Patil Medical College,Navi Mumbai , Thane, Maharashtra -400706
INDIA
Thane
MAHARASHTRA
400706
India |
| Phone |
9819192212 |
| Fax |
|
| Email |
arundhatibb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arundhati Barua |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General medicine,Dr DY Patil Medical College,Navi Mumbai , Thane, Maharashtra -400706
INDIA
Thane
MAHARASHTRA
400706
India |
| Phone |
9819192212 |
| Fax |
|
| Email |
arundhatibb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil Medical College and Hospital, Nerul Navi Mumbai 400706
Maharashtra , INDIA |
|
|
Primary Sponsor
|
| Name |
Bindukumar Patel KT |
| Address |
Junior Resident Department of General Medicine Dr DY 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 Bindukumar Patel KT |
Dr DY Patil Hospital, Navi Mumbai |
OPD 1 Ground floor General Medicine Department Dr DY Patil Hospital , Nerul, Navi Mumbai -400706
Thane
Maharashtra
Thane
MAHARASHTRA |
8277091799
ktbindukumar18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee(IEC) for Biomedical and Health Research, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
A Daignosed case of Non Alcoholic fatty liver Disease by Ultrasonography |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cardiovascular profile and events in Diagnosed case of Non Alcoholic fatty liver Disease |
5 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation Between Non Alcoholic Fatty Liver Disease and Cardiovascular Profile |
5 Yeras |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/02/2025 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is A Cross-Sectional Study to Determine Cardiovascular Profile of Patients Diagnosed with Non Alcoholic Fatty liver disease |