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Completed

NCT Number: NCT00443079

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

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.

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Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Diego Medical Center

San Diego, California, 92103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IdB 1016 (Siliphos)

Drug

1 pill 3 times daily x 6 weeks

Matched placebo

Drug

1 pill 3 times daily x 6 weeks

Primary outcomes

  1. Number of Study Participants With Adverse Events

    Time frame: 6 weeks

    Side effect profile was collected at each study visit as tracked by study participants. Any new onset symptoms reported by study participants were recorded as side effects of treatment and analyzed according to whether they occurred while participants were treated with placebo or Siliphos.

    An increase in ALT value to greater than or equal to 2 x baseline value was also evaluated for possible drug induced liver injury.

Secondary outcomes

  1. 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

    Time frame: 6 weeks

    Change in ALT value from baseline to end of treatment arm during the time treated with Placebo in comparison to the time treated with Siliphos. Significant change in ALT was defined as a decrease by 15 or more units from baseline to end of treatment period.

Sponsors and collaborators

Lead sponsor

Heather Patton

Other

Collaborators

  • American College of Gastroenterology

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 5, 2007
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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