NCT02637310已完成2 期
A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis
PharmaKing0 个研究点目标入组 108 人开始时间: 2015年12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
- 108
- 主要终点
- BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
研究概览
简要总结
A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis
详细描述
Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 19, under 75 of age
- •Patients acute bronchitis, sputum symptoms, BSS over 7 points.
- •Patients acute bronchitis within 7days.
- •Non-pregnant, patients who agree to contraception.
- •Patients who can write diary and available to communicate.
- •Patients voluntarily agreed
排除标准
- •Patients with hypersensitivity to the drug.
- •Patients who have gotten systemic steroid treatment within 4 weeks.
- •Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
- •Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
- •Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
- •Patients heart disease, severe kidney, liver disease.
- •The bleeding tendency or immunosuppressed patients.
- •Patients with clinically significant abnormal values.
- •Pregnant women or nursing mothers.
- •Patients alcoholics or drug abuse.
- •Patients taking other clinical trail's medicines within 30 days.
研究组 & 干预措施
N02RS1 1200mg
Experimental
Combination of Broussonetia spp and Lonicera spp
干预措施: N02RS1 1200mg (Drug)
Placebo
Placebo Comparator
sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
时间窗: Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)
次要结局
未报告次要终点
研究者
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