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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00443079
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : June 25, 2010
American College of Gastroenterology
Information provided by:
University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: IdB 1016 (Siliphos) Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)
Study Start Date : March 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Intervention Details:
  • Drug: IdB 1016 (Siliphos)
    1 pill 3 times daily x 3 months

Primary Outcome Measures :
  1. Safety, as determined by laboratory and clinical assessment, during and after treatment [ Time Frame: 4 months ]
  2. Tolerability, as determined by clinical assessment of side effects, during and after treatment [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Efficacy, determined by serial measurement of serum aminotransferase levels before, during, and after treatment [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00443079

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United States, California
University of California, San Diego Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
American College of Gastroenterology
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Principal Investigator: Heather M Patton, MD University of California, San Diego

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Responsible Party: Heather Patton, MD, UCSD Medical Center Identifier: NCT00443079     History of Changes
Other Study ID Numbers: 051117
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: June 2008
Keywords provided by University of California, San Diego:
Clinical Trials
Pilot Projects
Milk Thistle
Liver Function Tests
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases