Respiratory Conditions Due to Unspecified External Agent
Conditions
Keywords
Anti-pollution, green tea extracts
Brief summary
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
Interventions
AP green tea extracts
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function test | 4 weeks | Improvement in pulmonary function test |
| Respiratory health survey | 4 weeks | Patients' self evaluation of COPD Assessment Test |
| Biomarkers | 4 weeks | Blood concentration of biomarkers (Inflammatory cytokines) |
| Heavy metals | 4 weeks | Blood concentration of heavy metals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bronchial assessment | 4 weeks | Patients' self evaluation of Bronchiectasis Health Questionnaire |
Countries
South Korea