NCT01979926已完成2 期
Double-blind, A Multicenter, Randomized, Placebo-controlled, Parallel, Phase 2 Study to Comparative Evaluate the Efficacy of N02RS1 600mg/Day, 12,00mg/Day in Korean Patients With Acute and Chronic Bronchitis
PharmaKing1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18, under 75 years of age
- •Patients Acute and Chronic Bronchitis
排除标准
- •Patients who have gotten a glucocorticoids treatment within 4 weeks.
- •Patients who need treatments of antibiotic and acute bronchitis infection.
- •Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
- •Bronchial asthma patient.
- •Patients who have an indication of bleeding.
- •Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response.
- •Patients who have history of over 3 phage of Chronic obstructiv lung disease
- •Bronchiectasis patients.
研究组 & 干预措施
N02RS1 200mg
Experimental
Combination of Broussonetia spp and Lonicera spp
干预措施: Combination of Broussonetia spp and Lonicera spp (Drug)
N02RS1 400mg
Experimental
Combination of Broussonetia spp and Lonicera spp
干预措施: Combination of Broussonetia spp and Lonicera spp (Drug)
Placebo
Placebo Comparator
Sugar pill
干预措施: Combination of Broussonetia spp and Lonicera spp (Drug)
结局指标
主要结局
Safety
时间窗: 12weeks
1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
次要结局
- Efficacy(12weeks)
研究者
研究点 (1)
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