Anti-pollution Effects of AP Green Tea Extracts

Respiratory Conditions Due to Unspecified External Agent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340375
• Other study ID #: AP-R-2018-01
• Status: Completed
• Phase: N/A
• Start date: May 3, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

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

Related Conditions & MeSH terms

• Respiratory Conditions Due to Unspecified External Agent

Intervention

Dietary Supplement:
• AP green tea extracts
AP green tea extracts

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function test	Improvement in pulmonary function test	4 weeks
Primary	Pulmonary function test	Improvement in pulmonary function test	8 weeks
Primary	Respiratory health survey	Patients' self evaluation of COPD Assessment Test	4 weeks
Primary	Respiratory health survey	Patients' self evaluation of COPD Assessment Test	8 weeks
Primary	Biomarkers	Blood concentration of biomarkers (Inflammatory cytokines)	4 weeks
Primary	Biomarkers	Blood concentration of biomarkers (Inflammatory cytokines)	8 weeks
Primary	Heavy metals	Blood concentration of heavy metals	4 weeks
Primary	Heavy metals	Blood concentration of heavy metals	8 weeks
Secondary	Bronchial assessment	Patients' self evaluation of Bronchiectasis Health Questionnaire	4 weeks
Secondary	Bronchial assessment	Patients' self evaluation of Bronchiectasis Health Questionnaire	8 weeks