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

Heather Patton

Status and phase: Completed; Phase 2

Conditions: Fatty Liver

Treatments: Drug: Matched placebo; Drug: IdB 1016 (Siliphos)

Study type: Interventional

Funder types: Other

Identifiers

NCT00443079

051117

Details and patient eligibility

About

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.

Full description

Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of liver conditions characterized by fat accumulation in the liver. Non-alcoholic steatohepatitis (NASH) is one form of NAFLD that may progress to cirrhosis in some people. Currently, there are no medications that are approved for the treatment of NASH. Milk thistle is sold over-the-counter as a dietary supplement. Milk thistle has been used for hundreds of years as a supplement to support liver function, and is commonly taken by people with a variety of liver conditions. Milk thistle may help to reduce inflammation and fibrosis (scar tissue) in the liver, so it may be beneficial in the treatment of NASH. As NAFLD is very common in the population, there are probably many people with NAFLD taking milk thistle supplements. However, there are no published studies of milk thistle in NAFLD. Therefore, this study is designed to provide preliminary evidence of the safety, tolerability, and efficacy of milk thistle in people with NASH.

Comparison: The milk thistle supplement (called Siliphos) will be compared to a placebo (sugar pill) in this study.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Siliphos/Placebo

Experimental group

Description:

Received study medication first followed by placebo

Treatment:

Drug: IdB 1016 (Siliphos)

Drug: Matched placebo

Placebo/Siliphos

Experimental group

Description:

Received placebo first followed by study medicaiton

Treatment:

Drug: IdB 1016 (Siliphos)

Drug: Matched placebo