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

NCT00443079 | Completed Phase 2 Results

• 1 other identifier: 051117
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver

Keywords

Clinical Trials; Pilot Projects; Milk Thistle; Liver Function Tests

Outcome Measures

Primary Outcomes (1)

• Number of Study Participants With Adverse Events

  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 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

  6 weeks

Study Arms (2)

Siliphos/Placebo

EXPERIMENTAL

Received study medication first followed by placebo

Drug: IdB 1016 (Siliphos); Drug: Matched placebo

Placebo/Siliphos

EXPERIMENTAL

Received placebo first followed by study medicaiton

Drug: IdB 1016 (Siliphos); Drug: Matched placebo

Interventions

IdB 1016 (Siliphos) DRUG

1 pill 3 times daily x 6 weeks

Placebo/Siliphos; Siliphos/Placebo

Matched placebo DRUG

1 pill 3 times daily x 6 weeks

Placebo/Siliphos; Siliphos/Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver biopsy within 12 months demonstrating NASH
• Abnormal ALT

You may not qualify if:

• Uncontrolled diabetes
• Hepatitis B, hepatitis C, or other chronic liver conditions
• Abnormal kidney function
• Excess alcohol consumption

Sponsors & Collaborators

• Heather Patton: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

University of California, San Diego Medical Center

San Diego, California, 92103, United States

Location

Related Publications (1)

• Kidd P, Head K. A review of the bioavailability and clinical efficacy of milk thistle phytosome: a silybin-phosphatidylcholine complex (Siliphos). Altern Med Rev. 2005 Sep;10(3):193-203.

  PMID: 16164374 BACKGROUND

MeSH Terms

Conditions

Fatty Liver

Interventions

IdB 1016

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Heather Patton
• Organization: UCSDMED

hpatton@ucsd.edu

619-543-2470

Study Officials

• Heather M Patton, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professory

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Locations

US (1)