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Silymarin for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT02006498 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2016-01-08

No results posted yet for this study

Summary

This is a randomised study to examine whether high dose Sillymarin will be able to help improve fat-induced liver damage in the liver. The study hypothesis is that high dose Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better than placebo.

Conditions

  • Non-alcoholic Fatty Liver Disease

Interventions

DRUG

Sillymarin

Sillymarin is derived from the milk thistle plant, Silybum marianum, a herbal remedy that has been used for centuries for diseases of the liver. It is a complex mixture of 6 major flavonolignans (silybins A and B, isosilybins A and B, silychristin, and silydianin), as well as other minor polyphenolic compounds.

DRUG

Placebo

Placebo capsule with same appearances as study drug

Sponsors & Collaborators

  • Rottapharm

    collaborator INDUSTRY

  • University of Malaya

    lead OTHER

Principal Investigators

  • Sanjiv Mahadeva, MD, MRCP · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006498 on ClinicalTrials.gov