| CTRI Number |
CTRI/2024/08/072578 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of lipid profile in Decomensated chronic liver disease patients |
|
Scientific Title of Study
|
A cross sectional observation study of lipid
profile in chronic liver disease patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jay Bhadja |
| Designation |
Junior resident 2 |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil medical College, Navi Mumbai
Thane
MAHARASHTRA
Thane
MAHARASHTRA
400706
India |
| Phone |
9712885531 |
| Fax |
|
| Email |
jaybhadjajb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arundhati Barua |
| Designation |
Professor and HOU general medicine |
| Affiliation |
DY patil hospital navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil medical College, Navi Mumbai
Thane
MAHARASHTRA
MAHARASHTRA
400706
India |
| Phone |
9819192212 |
| Fax |
|
| Email |
arundhatibb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jay Bhadja |
| Designation |
Junior resident 2 |
| Affiliation |
DY patil hospital navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil medical College, Navi Mumbai
Thane
MAHARASHTRA
MAHARASHTRA
400706
India |
| Phone |
9712885531 |
| Fax |
|
| Email |
jaybhadjajb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. DY Patil Medical College and hospital, Nerul, Navi Mumbai 400706,India |
|
|
Primary Sponsor
|
| Name |
Jay Bhadja |
| 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 Jay Bhadja |
Dy Patil hospital, Navi Mumbai |
3rd floor, general medicine department E3A and E3B ward and 2nd floor micu 1 and 2
Thane
MAHARASHTRA |
9712885531
jaybhadjajb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K721||Chronic hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both genders above age of 12
2.Patients giving consent for the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women
2.Chronic kidney disease
3.Hematological and other malignancy
4.Recent intake of hepatotoxic and cholestatic drug |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess lipid profile abnormalities in patients with chronic liver disease. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study outcome is yet to come |
1 year |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
26/08/2024 |
| 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="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
|
AIMS AND OBJECTIVE: AIM : Feasibility of lipid profile as a prognostic marker in chronic liver disease
Primary objective: To assess lipid profile abnormalities in patients with chronic liver disease.
Secondary objective : To correlate that with severity of Chronic liver disease. Use of lipid profile as an additional marker in scoring system. |