Phase 2
N=6
A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
Fatty Liver
Bottom Line
View on ClinicalTrials.gov: NCT00443079 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Study Participants With Adverse Events — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IdB 1016 (Siliphos) (Drug); Matched placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Heather Patton
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Study Participants With Adverse Events |
0; 0 | — |
| SECONDARY Number of Participants With a Decrease in ALT Value Greater Than or Equal to 15 U/L From Baseline to the End of the Treatment Era |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Liver biopsy within 12 months demonstrating NASH
- Abnormal ALT
Exclusion Criteria
- Uncontrolled diabetes
- Hepatitis B, hepatitis C, or other chronic liver conditions
- Abnormal kidney function
- Excess alcohol consumption
Data sourced from ClinicalTrials.gov (NCT00443079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.