NCT03542721Unknown4 期
A Placebo-controlled, Randomized, Double-blind, Parallel, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
Dong-A Pharmaceutical1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2018年1月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- CIS(Checklist Individual Strength) less than or equal to 76
研究概览
简要总结
The aim of the present clinical study is to evaluate the efficacy and safety of the DA-5515 (Circulan Soft Cap.) in patients with chronic fatigue symptoms due to impaired blood circulation.
详细描述
This study is conducting to assess the efficacy and safety of the DA-5515 (Circulan Soft Cap.), which has been known to have a fatigue recovery effect due to impaired blood circulation.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford's category 0/0 or Ⅰ/1
- •ABI <1.0
- •CIS greater than 76
- •HADS less than or equal to 10
- •Subjects who have fatigue symptoms more than 1 month
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
Placebo of DA-5515 Capsule
Placebo Comparator
Placebo of DA-5515 (three times a day)
干预措施: Placebo of DA-5515 (Drug)
DA-5515 Capsule
Experimental
Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day)
干预措施: DA-5515 (Drug)
结局指标
主要结局
CIS(Checklist Individual Strength) less than or equal to 76
时间窗: 8weeks
Rate of subjects whose CIS score has improved less than or equal to 76 at 8weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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