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Silymarin-Choline Combination Versus Ursodeoxycholic Acid in Non-Alcoholic Fatty Liver Disease

Silymarin-Choline Combination Versus Ursodeoxycholic Acid in Non-Alcoholic Fatty Liver Disease: A Randomised Double-Blind Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018550
Enrollment
78
Registered
2019-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Silymarin-Choline: Silymarin-Choline Intervention2: Silymarin-Choline: Silymarin-Choline â?¢ Tablet Mariliv (Manufacturer: EMCEE Pharmaceuticals (P) Ltd.): A combination of Tablet Silym

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex from 18 years to 60 years 2. Patients diagnosed with Non Alcoholic Fatty Liver Disease attending Medicine OPD, Medical Gastroenterology OPD, Liver Clinic of Medical College and Hospital Kolkata

Exclusion criteria

Exclusion criteria: 1. Ethanol intake > 20 g/ day 2. History of ingestion of drugs known to produce fatty liver disease (such as steroids, estrogens, amiodarone, tamoxifen or other chemotherapeutic agents etc.) 3. Diabetes 4. Viral Hepatitis (HBV, HCV), HIV 5. Severely ill requiring hospital indoor services or critical care 6. Pregnancy

Design outcomes

Primary

MeasureTime frame
Primary: improvement in the -elevated liver enzyme level -Liver Stiffness Measurement (by non-invasive method, Transient Elastography) -Liver Inflammation and Fibrosis Score (by Metavir Scoring System, Subject to availability of Bard Max-Core Disposable Biopsy Gun 18 G) Timepoint: Baseline and 6 months—

Secondary

MeasureTime frame
â?¢Secondary: -monitoring and reporting associated adverse events (if any) -medication adherence of patientsTimepoint: Baseline and 6 months—

Countries

India

Contacts

Public ContactPurba Chakrabarty

Medical College, Kolkata

souvikpgi@gmail.com8017585988

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026