CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
IdB 1016 (Siliphos) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00443079
NCT00443079Phase 2Completed
CompareCT.gov

A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)

Heather Patton·interventional·Posted Mar 5, 2007·Updated Mar 24, 2021

In Brief

A Phase 2 clinical trial evaluating IdB 1016 (Siliphos) and Matched placebo for Fatty Liver. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatty Liver
CountriesUnited States
CollaboratorsAmerican College of Gastroenterology

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 5, 2007
Enrollment StartMar 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.3 years ago

Interventions

IdB 1016 (Siliphos)drug

1 pill 3 times daily x 6 weeks

Matched placebodrug

1 pill 3 times daily x 6 weeks