A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Study Participants With Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver biopsy within 12 months demonstrating NASH
- •Abnormal ALT
排除标准
- •Uncontrolled diabetes
- •Hepatitis B, hepatitis C, or other chronic liver conditions
- •Abnormal kidney function
- •Excess alcohol consumption
研究组 & 干预措施
Siliphos/Placebo
Received study medication first followed by placebo
干预措施: IdB 1016 (Siliphos) (Drug)
Siliphos/Placebo
Received study medication first followed by placebo
干预措施: Matched placebo (Drug)
Placebo/Siliphos
Received placebo first followed by study medicaiton
干预措施: IdB 1016 (Siliphos) (Drug)
Placebo/Siliphos
Received placebo first followed by study medicaiton
干预措施: Matched placebo (Drug)
结局指标
主要结局
Number of Study Participants With Adverse Events
时间窗: 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.
次要结局
- 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)
研究者
Heather Patton
Professory
University of California, San Diego