Anti-pollution Effects of AP Green Tea Extracts

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Respiratory Conditions Due to Unspecified External Agent

Intervention / Treatment
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* Dietary Supplement: AP green tea extracts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP green tea extracts<br>8 weeks | Dietary Supplement: AP green tea extracts<br>* AP green tea extracts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test | Improvement in pulmonary function test | 4 weeks | 
| Pulmonary function test | Improvement in pulmonary function test | 8 weeks | 
| Respiratory health survey | Patients' self evaluation of COPD Assessment Test | 4 weeks | 
| Respiratory health survey | Patients' self evaluation of COPD Assessment Test | 8 weeks | 
| Biomarkers | Blood concentration of biomarkers (Inflammatory cytokines) | 4 weeks | 
| Biomarkers | Blood concentration of biomarkers (Inflammatory cytokines) | 8 weeks | 
| Heavy metals | Blood concentration of heavy metals | 4 weeks | 
| Heavy metals | Blood concentration of heavy metals | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchial assessment | Patients' self evaluation of Bronchiectasis Health Questionnaire | 4 weeks | 
| Bronchial assessment | Patients' self evaluation of Bronchiectasis Health Questionnaire | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-pollution, green tea extracts