NCT05683951已完成3 期
Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Bronchitis severity score (BSS)
研究概览
简要总结
Randomized, Double-blind, Parellel, Multicenter, Active-controlled
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged between 19 and
- •Patients whose BSS score is over 5.
排除标准
- •Patients allergic to any ingredients of the study drugs.
- •Moderate liver disease (ALT or AST > UNLx3).
- •Moderate lung disease.
- •Uncontrolled HTN.
- •Uncontrolled DM.
- •Uncontrolled thyroidism.
- •Patients who is needed antibiotics during the study period.
- •In the case of women, pregnant(Urine-HCG positive) or lactating women.
研究组 & 干预措施
DWKH
Experimental
干预措施: DWKH (Drug)
DWKH-R
Active Comparator
干预措施: DWKH-R (Drug)
PLACEBO
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Bronchitis severity score (BSS)
时间窗: 0,4,7 days
Difference of the BSS score (0 to 4, higher score means more severe)
次要结局
未报告次要终点
研究者
研究点 (1)
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