NCT02978339已完成1 期
An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis
John E. Eaton1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年6月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Serum Alkaline Phosphatase (SAP)
研究概览
简要总结
The purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (PSC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of primary sclerosing cholangitis (PSC) established by all of the following criteria:
- •Alkaline phosphatase >1.5x upper limit of normal for at least 6 months prior to study enrollment
- •Cholangiography demonstrating intrahepatic and/or extrahepatic biliary dilation, beading, and/or strictures consistent with PSC
- •Liver histology (if available for review) consistent with or diagnostic of PSC
- •Women of child-bearing potential willing to use birth control for the duration of the study.
排除标准
- •Treatment with any investigational agents within three months prior to or during the study
- •Treatment with systemic antibiotics, azulfidine, systemic corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, or vitamin E within three months prior to or during the study.
- •Concomitant treatment with NSAIDS, antiplatelet agents, antihyperlipidemics, and anticoagulant warfarin.
- •Anticipated need for liver transplant within one year as determined by Mayo PSC risk score (<80% one-year survival without transplant)
- •Active drug or alcohol use
- •Findings suggestive of liver disease of an alternative or concomitant etiology, such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis (e.g., post-liver transplantation biliary stricture)
- •Pregnancy or lactation
- •Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
研究组 & 干预措施
Curcumin
Experimental
Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.
干预措施: Curcumin (Drug)
结局指标
主要结局
Change in Serum Alkaline Phosphatase (SAP)
时间窗: baseline, 12 weeks
Number of subjects who experience a reduction of Serum Alkaline Phosphatase (SAP) to less than 1.5 x Upper Limit of Normal or a 40% reduction between baseline and week 12.
次要结局
- Change in Serum Aspartate Aminotransferase (AST)(Baseline, 12 weeks)
- Change in C-Reactive Protein (CRP)(Baseline, 12 weeks)
- Change in Fatigue Severity(Baseline, 12 weeks)
- Change in Total Bilirubin(Baseline, 12 weeks)
- Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score(Baseline, 12 weeks)
- Change in Pruritus(Baseline, 12 weeks)
研究者
John E. Eaton
Principal Investigator
Mayo Clinic
研究点 (1)
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