- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443079
A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- University of California, San Diego Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Siliphos/Placebo
Received study medication first followed by placebo
|
1 pill 3 times daily x 6 weeks
1 pill 3 times daily x 6 weeks
|
Experimental: Placebo/Siliphos
Received placebo first followed by study medicaiton
|
1 pill 3 times daily x 6 weeks
1 pill 3 times daily x 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather M Patton, MD, University of California, San Diego
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 051117
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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