NCT02418130已完成4 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 'Ursa Complex Soft Cap. (UDCA-004)' in Patients With Physical Fatigue.
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 166 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
- 166
- 试验地点
- 1
- 主要终点
- Rate of subjects whose CIS score has improved under 76 at week 4
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 Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.
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
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
UDCA004
Experimental
UDCA004
干预措施: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol (Drug)
Placebo of UDCA004
Placebo Comparator
Placebo of UDCA004
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of subjects whose CIS score has improved under 76 at week 4
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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