A Pilot Study of Siliphos in Adults With Non-Alcoholic Steatohepatitis (NASH) - NCT00443079-92103 (Clinical Trial 164500)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy164500.aspx
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92103 |
| Conditions: |
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Fatty Liver |
| Purpose: |
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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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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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University of California, San Diego Medical Center
San Diego, CA 92103
United States
Primary Contact:
Heather M Patton, MD
Email: hpatton@ucsd.edu
Phone: 619-471-0291
Secondary Contact:
Heather M Patton, MD
Email: hpatton@ucsd.edu
Phone: 619-471-0291 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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