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| Name | Class |
|---|---|
| American College of Gastroenterology | OTHER |
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siliphos/Placebo | Experimental | Received study medication first followed by placebo |
|
| Placebo/Siliphos | Experimental | Received placebo first followed by study medicaiton |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IdB 1016 (Siliphos) | Drug | 1 pill 3 times daily x 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather M Patton, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego Medical Center | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16164374 | Background | 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. |
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There were no participants who were excluded from study between informed consent/screening visit and study group allocation/randomization.
Adults with biopsy-proven NASH were recruited from outpatient hepatology clinics. Liver biopsy had to be within the previous year (no liver biopsies were done specifically to enroll in the study). ALT was elevated (normal ALT defined as 30U/L for men and 20U/L for women) and other types of chronic liver disease (viral hepatitis, alcohol, autoimmune) evaluated and excluded. Baseline kidney function was also normal (creatinine less than or equal to 1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Siliphos/Placebo | Subjects treated with study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks with 2 weeks of washout followed by placebo 1 pill by mouth three times daily for 6 weeks |
| FG001 | Placebo/Siliphos | Subjects treated with placebo 1 pill by mouth three times daily for 6 weeks with 2 weeks of washout followed by study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Siliphos/Placebo | Subjects treated with Siliphos (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by placebo (1 pill by mouth three times daily) for 6 weeks |
| BG001 | Placebo/Siliphos |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | side effects and adverse events were gathered from study participants at each clinic visit | Posted | Count of Participants | Participants | 6 weeks |
|
Adverse event data were collected from the beginning of the treatment through the end of follow-up (at time of last clinic visit, week 16 or 2 weeks after end of medication administration).
Study participants were given journals to record any symptoms that may have emerged during treatment and asked to bring these with them to each study visit for investigator review and recording. Additional details about symptoms to be reviewed during study visits with investigator as they occur.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Siliphos | Siliphos 1 pill by mouth three times daily for 6 weeks (combined for all participants) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Patton | UCSDMED | 619-543-2470 | hpatton@ucsd.edu |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C067772 | IdB 1016 |
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| Matched placebo | Drug | 1 pill 3 times daily x 6 weeks |
|
Subjects treated with Placebo (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by Siliphos (1 pill by mouth three times daily) for 6 weeks
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Placebo | Adverse events were evaluated for all participants during the time period that they received placebo. Placebo: 1 pill 3 times daily x 6 weeks |
|
|
| Secondary | 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 | 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. | Number participants with a decrease in ALT value greater than or equal to 15 U/L from baseline to the end of the treatment era. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | Placebo 1 pill by mouth three times daily for 6 weeks (combined for all participants) | 0 | 6 | 0 | 6 | 0 | 6 |
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