| CTRI Number |
CTRI/2024/05/066754 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of hsCRP as a marker of severity in patients with non alcoholic fatty liver disease |
|
Scientific Title of Study
|
Clinical profile of non alcoholic fatty liver disease and significance of hsCRP |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanju George |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal academy of higher education |
| Address |
Department of General Medicine second floor OPD block Kasturba Medical College, Manipal Karnataka 576104
Department of General Medicine second floor OPD block Kasturba Medical College, Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9980976396 |
| Fax |
|
| Email |
sanju.george.home@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raviraja V Acharya |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba Medical College, Manipal academy of higher education |
| Address |
Department of General Medicine second floor OPD block Kasturba Medical College, Manipal Karnataka 576104
Department of General Medicine second floor OPD block Kasturba Medical College, Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845471000 |
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Siddharth Gosavi |
| Designation |
Senior Resident |
| Affiliation |
Kasturba medical college manipal, MAHE |
| Address |
Department of General Medicine second floor OPD block Kasturba Medical College, Manipal Karnataka 576104
Department of General Medicine second floor OPD block Kasturba Medical College, Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9632145400 |
| Fax |
|
| Email |
gosavi.siddharth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Sanju George |
| Address |
Department of General Medicine second floor OPD block Kasturba Medical College, Manipal Karnataka 576104 a |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sanju George |
Kasturba hospital |
Department of General Medicine second floor OPD block Kasturba Medical College KMC Manipal
Udupi KARNATAKA
Udupi
KARNATAKA |
9980976396
sanju.george.home@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital I Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil since it is observational study |
Nil since it is observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to Kasturba Hospital during the study period who’s USG shows grade 2 or 3 fatty infiltration of the liver. |
|
| ExclusionCriteria |
| Details |
Patients with history of significant/hazardous levels of alcohol consumption (ie. more than one drink per day in women and two drinks per day in men based on epidemiologic evidence that the prevalence of serum aminotransferase elevations increases when alcohol consumption habitually exceeds these levels. In those studies, one drink was defined as having 10 g of ethanol and, thus, is equivalent to one can of beer, 4 oz of wine, or 1.5 oz (one shot) of distilled spirits.), Patients with Connective Tissue disorders, Patients with chronic kidney disease, Patients with acute or chronic Hepatitis B or C infections, Patients with recent history of trauma, Patients with malignancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Predict severity of Non
Alcoholic Fatty liver by using hsCRP |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Justification for study: Non alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. The global prevalence of Non alcoholic fatty liver disease is estimated to be as high as one billion. Liver biopsy being the gold standard, is too invasive, there’s a chance of sampling error and costly. There is a pressing need for more viable non invasive markers of severity. Timely intervention can revert the disease progression and play a significant role in bringing down the morbidity associated with the disease
Detailed description of procedure / processes: All patients admitted to Kasturba Hospital in the study period who are diagnosed as grade 2 and grade 3 fatty infiltration on USG abdomen, who meet the inclusion, exclusion criteria will be recruited for the study. Written and informant consent will be taken from the participants before initiating the study. Anthropometric data, investigative data including hsC-reactive protein levels and elastoscan reports are obtained from the proforma. Non alcoholic fatty liver fibrosis score and FIB4 score will be calculated using parameters obtained from the proforma. The above data will be compared and analyzed. Outcome measures include significance of hsCRP in NAFLD in predicting severity of NAFLD, study clinical profile of NAFLD, accuracy of non-invasive scoring systems of NAFLD
|