Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.
详细描述
This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients should had no excessive alcohol intake or use of any hepatoprotective or hepatotoxicity medication within 3 months before enrollment.Patients will have an screening period 12 weeks, and a 48-week double-blinded treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Berberine
Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
干预措施: Lifestyle intervention (Behavioral)
Berberine
Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
干预措施: Berberine (Drug)
Placebo
Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
干预措施: Lifestyle intervention (Behavioral)
Placebo
Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS)
时间窗: 48 weeks
A separate system of scoring the histological features of nonalcoholic fatty liver disease (NAFLD) called the NAFLD Activity Score (NAS) was used. An improvement in histologic findings require an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.
次要结局
- Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning(48 weeks)
- Change in serum cytokeratin 18 (CK-18) in U/L(48 weeks)
- Improvement in liver histological fibrosis staging(48 weeks)
- Change in anthropometric measures(48 weeks)
- Change in blood biochemistry(48 weeks)
- Resolution of NASH(48 weeks)
- Change in liver fat content(48 weeks)