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A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)

NCT00443079 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-03-24

Study results available
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Summary

The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from milk thistle, to determine whether it is safe and well-tolerated in adults who have non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in people with NASH and will result in a decrease in the liver enzymes ALT and AST.

Conditions

Interventions

DRUG

IdB 1016 (Siliphos)

1 pill 3 times daily x 6 weeks

DRUG

Matched placebo

1 pill 3 times daily x 6 weeks

Sponsors & Collaborators

  • American College of Gastroenterology

    collaborator OTHER

  • Heather Patton

    lead OTHER

Principal Investigators

  • Heather M Patton, MD · University of California, San Diego

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00443079 on ClinicalTrials.gov