NCT01151202已完成3 期
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup" in Acute Upper Respiratory Tract Infection and Chronic Inflammatory Bronchitis Patients: Double Blinded, Randomized, Active Drug Comparative, Parallel Designed, Multi-centered, Phase III Study
Ahn-Gook Pharmaceuticals Co.,Ltd6 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 6
- 主要终点
- improvement by global assessment
研究概览
简要总结
The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory 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
- 24 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent
- •Patient ages between 24months and 75years
- •Patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing
- •Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection
排除标准
- •Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis
- •Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders
- •Patient whose fructose intolerance
- •Patient who has hypersensitivity anamnesis of Prospan syrup
- •Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant
- •Patient whose liver or kidney function is serious abnormal: including the cases of ALT, AST, bilirubin and blood creatinine value exceeding three times of their upper limit, severe liver disorders, chronic kidney disease
- •Patient who has uncontrolled diabetes or uncontrolled hypertensions
- •Patient who has experience to have participated in other clinical trial within two months before starting the trial
- •Pregnant women, lactating women
研究组 & 干预措施
AG NPP709 syrup
Experimental
AG NPP709 contains Ivy leaf extract and coptis rhizoma extract
干预措施: AG NPP709syrup (Drug)
Ivy leaf extract syrup
Active Comparator
干预措施: AG NPP709syrup (Drug)
结局指标
主要结局
improvement by global assessment
时间窗: 5 days
At closing visit, researcher assess clinical efficacy using the following five criteria (4: cure, 3: significant improvement, 2: improvement, 1: some improvement, 0: non-improvement or worsening of symptoms). Upper the Grade 3 outcomes are defined as "clinical success".
次要结局
- determine safety by unwanted reaction, clinical laboratory test and physical examination(5 days)
研究者
研究点 (6)
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