| CTRI Number |
CTRI/2023/05/052714 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Trial Depicting Factors Associated with NAFLD and their effect on Severity of NAFLD |
|
Scientific Title of Study
|
Clinical Study Of Factors Affecting Severity Of NAFLD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ansh Chaudhary |
| Designation |
MD Student |
| Affiliation |
Kasturba Hospital And Medical College Manipal |
| Address |
Department Of Medicine Kasturba Hospital and Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8171370149 |
| Fax |
|
| Email |
ansh2697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ansh Chaudhary |
| Designation |
MD Student |
| Affiliation |
Kasturba Hospital And Medical College Manipal |
| Address |
Department Of Medicine Kasturba Hospital and Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8171370149 |
| Fax |
|
| Email |
ansh2697@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cynthia Amrutha |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital And Medical College Manipal |
| Address |
Department of Medicine Kasturba Hospital and Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7259415415 |
| Fax |
|
| Email |
cynthiaamrutha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital And Medical College Manipal,576104 |
|
|
Primary Sponsor
|
| Name |
Dr Ansh Chaudhary |
| Address |
Department Of Medicine Kasturba Hospital And Medical College, Manipal, 576104 |
| 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 |
| Dr Ansh Chaudhary |
Kasturba Hospital |
Department Of Medicine Kasturba Hospital and Medical College, Manipal-576104
Udupi
KARNATAKA |
8171370149
ansh2697@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital 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 |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1)Age more than 18 Years
2)All patients diagnosed as fatty liver by abdominal ultrasonography
|
|
| ExclusionCriteria |
| Details |
1)chronic liver diseases, including hepatitis B or C
2)alcoholic liver disease.
3)Patients on hepatotoxic medications.
4)Advanced liver disease
5)Cardiac failure
6)Acute fatty liver of pregnancy
7)Patients known case of Autoimmune Hepatitis
8)Any known Malignancy
9)Patients not giving consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Occurrence Of Vit B12 Deficiency In NAFLD
2) Occurrence of Thyroid Abnormalities in NAFLD
3) Diagnostic Accuracies of Predictive scoring systems in NAFLD
|
1.5 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Occurrence Of Vit B12 Deficiency In NAFLD
2) Occurrence of Thyroid Abnormalities in NAFLD
3) Diagnostic Accuracies of Predictive scoring systems in NAFLD
|
2 years |
|
|
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)
|
01/07/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an observational cross sectional study, to study severity of vit B12 deficiency , to evaluate thyroid dysfunction and to find diagnostic accuracies of AST/ALT Ratio, APRI, FIB4 scoring systems for predicting severity of NAFLD in 100 patients admitted in ward of Kasturba Hospital, Manipal and fitting into the inclusion and exclusion criteria. |