NCT02151734已完成3 期
Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
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
- 242
- 主要终点
- Total score of BSS(Bronchitis Severity Score)
研究概览
简要总结
This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.
The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 12-75 years old
- •A total score of BSS ≥ 5
- •The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
- •Patients who voluntarily sign a written informed consent to participate in the trial
排除标准
- •Indication for antibiotic treatment(e.g. severe respiratory infection)
- •Allergic bronchial asthma
- •Tendency to bleed
- •Severe heart, renal, or liver diseases or decline of immune function
- •Chronic obstructive pulmonary disease
- •Known or supposed hypersensitivity to investigational medication
- •Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial
- •Women during pregnancy or lactation period
- •Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)
- •Participation in any other trial within 30 days prior to inclusion in the trial
- •Unsuitable patients for enrollment in the opinion of the investigator
研究组 & 干预措施
KALOMIN™ Tab.
Experimental
KALOMIN™ Tab./Placebo to Umckamin syrup
干预措施: KALOMIN™ Tab. (Drug)
Umckamin syrup
Active Comparator
Umckamin syrup/Placebo to KALOMIN™ Tab.
干预措施: Umckamin syrup (Drug)
结局指标
主要结局
Total score of BSS(Bronchitis Severity Score)
时间窗: 7days
次要结局
- Individual symptom score of BSS(7days)
- reaction rate of treatment(7days)
- IMOS(Integrative Medicine Outcome Scale)(7days)
- IMPSS(Integrative Medicine Patient Satisfaction Scale)(7days)
- Adverse events, clinical laboratory examination, physical examination, etc.(7 days)
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