| CTRI Number |
CTRI/2025/10/095986 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Disease of liver due to non-alcoholic causes. |
|
Scientific Title of Study
|
Prevalence And Determinants Of Metabolic Associated Fatty Liver Disease (MAFLD) Among People Residing In Urban And Rural Areas Of Belagavi-Community Based Comparitive 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 |
Dr Amrutha K |
| Designation |
Post-graduate student |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi. |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9496856750 |
| Fax |
|
| Email |
amruthak1211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh R Kulkarni |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi. |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9886010047 |
| Fax |
|
| Email |
rajesh2kulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha K |
| Designation |
Post-graduate student |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi. |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9496856750 |
| Fax |
|
| Email |
amruthak1211@gmail.com |
|
|
Source of Monetary or Material Support
|
| J N MEDICAL COLLEGE BELAGAVI KARNATAKA 590010 |
|
|
Primary Sponsor
|
| Name |
Dr. AMRUTHA K |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, Belagavi, Karnataka - 590010 |
| 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 AMRUTHA K |
KAHER Jawaharlal Nehru Medical College |
Department of Community Medicine Jawaharlal Nehru Medical College KLE University Campus Nehru Nagar Belagavi
Belgaum
KARNATAKA |
09496856750
amruthak1211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants aged more than 18 years and less than 65 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years and less than 65 years, residing in the same area for more than 1 year. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of alcohol intake more than 30 grams/ day in males and more than 20 grams/day in females.
2. Patients with history of jaundice or HBsAg positive and Hepatitis “C” positive.
3. Patients with history of following drug intake steroids, synthetic oestrogens, heparin, calcium channel blockers, amiodarone, valproic acid, arsenic, mercury, homeopathic drugs, ayurvedic drugs, antiviral agents.
4. Patients having autoimmune hepatitis.
5. History of drug abuse, opium, and nicotine.
6. Patients of Coronary artery disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective: To evaluate the prevalence and determinants of Metabolic Associated Fatty Liver Disease (MAFLD) among people residing in urban and rural areas
|
50 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objective: To assess the knowledge, awareness and attitude regarding Metabolic Associated Fatty Liver Disease (MAFLD) among people residing in urban and rural areas |
50 weeks |
|
|
Target Sample Size
|
Total Sample Size="402"
Sample Size from India="402"
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)
|
27/10/2025 |
| 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 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
|
India, with its rapidly developing
economy and changing lifestyle, is witnessing a surge in non-alcoholic fatty
liver disease (NAFLD), now termed metabolic dysfunction-associated fatty liver
disease (MAFLD). MAFLD encompasses a spectrum of liver damage, from simple
steatosis to cirrhosis and hepatocellular carcinoma, often associated with
metabolic syndrome, diabetes, and dyslipidemia. Globally, NAFLD affects
approximately 25% of the population, with India’s prevalence ranging from 6.7%
to 55.1%. Urban areas show a higher prevalence (40.0%) compared to rural areas
(29.2%). MAFLD’s new diagnostic criteria emphasize metabolic disorders,
allowing for diagnosis regardless of alcohol consumption or co-existing liver
diseases. While liver biopsy is the gold standard for diagnosis, non-invasive
tools like vibration-controlled transient elastography (VCTE) are increasingly
used to assess liver fibrosis and steatosis. As lifestyle and health factors
evolve, MAFLD is projected to become the leading cause of chronic liver disease
globally.
This study aims to assess the
prevalence and determinants of MAFLD among adults in urban and rural Belagavi,
informing public health research and prevention strategies. |