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

March 1, 2021 updated by: Heather Patton

A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients 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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92103
        • University of California, San Diego Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Heather M Patton, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimate)

March 5, 2007

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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