Double-blind, Randomized, Placebo Controlled, Multicenter, Phase IV Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet (Streptokinase • Streptodornase) in Patients With Acute Upper Respiratory Infection or Acute Bronchitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Change from baseline in BSS (Bronchitis Severity Score)
研究概览
简要总结
A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)
详细描述
Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute upper respiratory infection or acute bronchitis
- •Patients with cough and phlegm within 48 hrs as of Visit 1
- •Patients understood the consents and purpose of this trial and signed consent form
排除标准
- •Patients with high fever (≥39℃)
- •Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc.
- •Patients with a history of hypersensitivity to drug
- •Patients with abnormal blood coagulation
- •Patients with thrombocytopenia
- •Patients with uncontrolled hypertension
- •Patients with a severe liver disorder(AST or ALT level exceeds 2 times more than normal upper range)
- •Patients woth a clinically significant renal failure(MDRD eGFP < 60 mL/min/1.73m2)
研究组 & 干预措施
Mucolase
干预措施: MUCOLASE tablet (streptokinase • streptodornase) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in BSS (Bronchitis Severity Score)
时间窗: baseline, 7 days
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
次要结局
- Change from baseline in each symptom score of BSS (Bronchitis Severity Score)(baseline, 7 days)
- Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score)(baseline, 7 days)
- Complete resolution rate of each symptom(7 days)
- The number of use of relief drugs(7 days)
- Integrative Medicine Outcomes Scale(7 days)
- Integrative Medicine Patient Satisfaction Scales(7 days)