NCT04340375已完成不适用
A Clinical Study to Evaluate the Anti-pollution Effects of AP Green Tea Extracts in Subjects With Discomforts Related to the Respiratory System by Prolonged Exposure to Particulate Matter in Air Pollution
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pulmonary function test
研究概览
简要总结
The objective of this clinical trial is to evaluate the anti-pollution effects of AP green tea extracts in subjects with discomforts related to the respiratory system by prolonged exposure to particulate matter in air pollution
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 19 years or over
- •Subjects with discomforts related to the respiratory system by prolonged exposure to particulate matter in air pollution
- •Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives
排除标准
- •At the screening visit, subjects who were diagnosed with acute or chronic respiratory disease and undergoing medication.
- •Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
- •Subjects who show a level of ALT/AST of 2 times or more the upper limit of normal as a result of a screening test and have acute or chronic hepatitis or known liver cirrhosis
- •In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion
结局指标
主要结局
Pulmonary function test
时间窗: 8 weeks
Improvement in pulmonary function test
Heavy metals
时间窗: 8 weeks
Blood concentration of heavy metals
Respiratory health survey
时间窗: 8 weeks
Patients' self evaluation of COPD Assessment Test
Biomarkers
时间窗: 8 weeks
Blood concentration of biomarkers (Inflammatory cytokines)
次要结局
- Bronchial assessment(8 weeks)
研究者
研究点 (1)
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