Anti-pollution Effects of AP Green Tea Extracts

June 15, 2021 updated by: Amorepacific Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AP green tea extracts
8 weeks
Dietary supplement: AP green tea extracts
AP green tea extracts

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amorepacific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2019

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AP-R-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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