| CTRI Number |
CTRI/2026/02/104763 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Fatty Liver Disease: Symptoms and the Role of Ferritin Levels |
|
Scientific Title of Study
|
CLINICAL PROFILE OF MAFLD PATIENTS AND EVALUATION OF FERRITIN LEVEL AS A MARKER OF SEVERITY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aniruddha M |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Medicine
kasturba hospital manipal,Smt. Sharada Madhav Pai OPD , 2nd Floor .
Madhav Nagar, Near Tiger Circle, Manipal, Udupi District, Karnataka 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
9380456686 |
| Fax |
|
| Email |
anivani.20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raviraja V Acharya |
| Designation |
Professor and Head of unit |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Medicine
kasturba hospital manipal,Smt. Sharada Madhav Pai OPD , 2nd Floor .
Madhav Nagar, Near Tiger Circle, Manipal, Udupi District, Karnataka 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845471000 |
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raviraja V Acharya |
| Designation |
Professor and Head of unit |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Medicine
kasturba hospital manipal,Smt. Sharada Madhav Pai OPD , 2nd Floor .
Madhav Nagar, Near Tiger Circle, Manipal, Udupi District, Karnataka 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845471000 |
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| MMERW Manipal Trust
Madhav Nagar, Near Tiger Circle, Manipal, Udupi District, Karnataka 576104, India |
|
|
Primary Sponsor
|
| Name |
Dr Aniruddha M |
| Address |
Dr Aniruddha M
B604, Mandavi paradise, Vidyaratna Nagar, Manipal, Karnataka 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 Aniruddha M |
Kasturba Hospital Manipal |
Department of General Medicine,
Smt. Sharada Madhav Pai OPD , 2nd floor .
Madhav Nagar, Near Tiger Circle, Manipal, Udupi District, Karnataka 576104, India
Udupi
KARNATAKA |
9380456686
anivani.20@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 |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with MAFLD with or without hepatic fibrosis
Both sexes included
Age more than 18 years |
|
| ExclusionCriteria |
| Details |
Patients with medical history, clinical or laboratory evidence of any other liver diseases such as
alcoholic or Viral hepatitis, autoimmune liver disease, genetic liver disorders (e.g., Wilson’s
disease), and drug-induced liver injury and those with decompensated liver cirrhosis
Serum ferritin levels more than 1000ng/ml
Patients with iron deficiency anemia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The association between baseline serum ferritin levels and severity of MAFLD, assessed by liver fibrosis stage, measured at the time of enrollment . |
nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
12/03/2026 |
| 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="4"
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
|
MAFLD has become the most common chronic liver disease globally with its prevalence rising alongside the global epidemics of obesity type 2 diabetes and metabolic syndrome Understanding the factors contributing to its development and progression is critical to public health The study may have broad implications for public health particularly in populations at risk for MAFLD such as those with obesity diabetes and metabolic syndrome By understanding the correlation between ferritin and MAFLD targeted screening programs could be developed especially for individuals who are at risk of developing more severe forms of liver disease
If a strong relationship is established between ferritin levels and MAFLD it could offer a potential therapeutic target Elevated ferritin might indicate iron overload which has been shown to exacerbate liver injury and fibrosis Understanding whether lowering ferritin levels through interventions like phlebotomy or iron chelation could mitigate MAFLD progression might lead to new treatment options or preventative strategies |