A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Actein Effervescent Tablets 600MG in COPD Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.
研究概览
简要总结
To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.
详细描述
The study will enroll 40~60 patients and complete 40 patients.
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
- None
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
- •Subjects aged older than 20~75 years old.
- •Able to sign informed consent prior to the study.
- •Subjects have COPD.
排除标准
- •Subjects with known hypersensitivity to Acetylcysteine preparations.
- •Subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.)
- •Pregnancy or breast-feeding woman.
- •Female subjects or their sexual partners do not use contraception during the trial.
- •Joining any drug clinical trial within 3 months prior to dosing.
- •Investigator considered to be inappropriate for enrollment.
- •Phenylketonuria (PKU).
研究组 & 干预措施
Taneasy 600mg granules
Dose： 600 mg/time. Use ：two times per day.
干预措施: Taneasy 600mg granules (Drug)
Actein effervescent tablets 600MG
Dose： 600 mg/time. Use ：two times per day
干预措施: Actein effervescent 600mg (Drug)
结局指标
主要结局
To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.
时间窗: one month
Primary Evaluation Criteria: CAT score (COPD Assessment Test) The maximum score is 40. Higher scores indicate your COPD has a greater impact on your overall health and well-being.
次要结局
未报告次要终点