Anti-pollution Effects of AP Green Tea Extracts

Not Applicable

Completed

• Conditions: Respiratory Conditions Due to Unspecified External Agent
• Interventions: Dietary Supplement: AP green tea extracts

• Registration Number: NCT04340375
• Lead Sponsor: Amorepacific Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-03
• Primary Completion: 2020-02-28
• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Study Completion: 2020-04-30
• Status Verified: 2020-05
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AP green tea extracts	AP green tea extracts	8 weeks

Primary Outcome Measures

Name	Time	Method
Pulmonary function test	8 weeks	Improvement in pulmonary function test
Heavy metals	8 weeks	Blood concentration of heavy metals
Respiratory health survey	8 weeks	Patients' self evaluation of COPD Assessment Test
Biomarkers	8 weeks	Blood concentration of biomarkers (Inflammatory cytokines)

Secondary Outcome Measures

Name	Time	Method
Bronchial assessment	8 weeks	Patients' self evaluation of Bronchiectasis Health Questionnaire

Trial Locations

Locations (1)

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of