CompletedNCT04340375Updated Jun 16, 2021

Anti-pollution Effects of AP Green Tea Extracts

An interventional study of AP green tea extracts in Respiratory Conditions Due to Unspecified External Agent, sponsored by Amorepacific Corporation. Completed at 1 site in South Korea. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-16.

Sponsored by Amorepacific Corporation · Not applicable, Interventional, and Other

From the registry’s dates

Registered 10 months after the study started (first participant enrolled May 2019, registered Mar 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Not applicable
Ages: 19 Years to 70 Years
Sex: All

Study 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

Conditions studied

Respiratory Conditions Due to Unspecified External Agent

Keywords

Anti-pollution
green tea extracts

In context

Lead sponsor

Amorepacific Corporation is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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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

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

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
AP green tea extracts
8 weeks
Dietary Supplement: AP green tea extracts

Interventions

Dietary supplementAP green tea extracts
AP green tea extracts

What researchers measure

Primary outcomes

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

Secondary outcomes

Bronchial assessment
Patients' self evaluation of Bronchiectasis Health Questionnaire
Time frame: 4 weeks
Bronchial assessment
Patients' self evaluation of Bronchiectasis Health Questionnaire
Time frame: 8 weeks

Study locations

1 site

Hanyang University Seoul Hospital
Seoul, South Korea

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Feb 2020, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 31, 2020
First posted: Apr 9, 2020
StartActual: May 3, 2019
Primary completionActual: Feb 28, 2020
CompletionActual: Apr 30, 2020
Last update: Jun 16, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04340375
Lead sponsor: Amorepacific Corporation
Responsible party: Sponsor
First posted: Apr 9, 2020
Start date: May 3, 2019
Primary completion: Feb 28, 2020
Completion: Apr 30, 2020
Last update: Jun 16, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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