NCT02415777已完成4 期
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Rate of subjects whose CIS score has improved under 76 at week 8
研究概览
简要总结
A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CIS greater than or equal to 76, HADS less than or equal to 10
- •ALT greater than upper limit of normal OR fatty liver on US
排除标准
- •Subjects who have diseases that can cause fatigue
- •Subjects who are taking medication that can cause fatigue
研究组 & 干预措施
udca003
Experimental
udca003
干预措施: Ursodeoxycholic acid, thiamine, riboflavin (Drug)
placebo
Placebo Comparator
placebo of udca003
干预措施: Ursodeoxycholic acid, thiamine, riboflavin (Drug)
结局指标
主要结局
Rate of subjects whose CIS score has improved under 76 at week 8
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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