Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of HLIM
详细描述
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
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
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 and 75
- •Weight more than 11.5 kg
排除标准
- •Has a history of hypersensitivity to IP ingredients
- •Hypertension or Diabetes
- •Smoking more than 20 pack-years
研究组 & 干预措施
HLIM
HLIM+SA160021 Placebo+SA160022 Placebo
干预措施: Test (Drug)
SA160021
HLIM Placebo+SA160021+SA160022 Placebo
干预措施: Active Comparator Control 1 (Drug)
SA160022
HLIM Placebo+SA160021 Placebo+SA160022
干预措施: Active Comparator Control 2 (Drug)
Placebo
HLIM Placebo+SA160021 Placebo+SA160022 Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
时间窗: 5 days
0(absent) \~ 4(very severe), Total Score: 0\~20
Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group
时间窗: 5 days
0(absent) \~ 4(very severe), Total Score: 0\~20
次要结局
未报告次要终点