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OpenTrials
Completed

NCT Number: NCT04340375

Anti-pollution Effects of AP Green Tea Extracts

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

Completed

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang University Seoul Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AP green tea extracts

Dietary Supplement

AP green tea extracts

Primary outcomes

  1. Pulmonary function test

    Time frame: 4 weeks

    Improvement in pulmonary function test

  2. Pulmonary function test

    Time frame: 8 weeks

    Improvement in pulmonary function test

  3. Respiratory health survey

    Time frame: 4 weeks

    Patients' self evaluation of COPD Assessment Test

  4. Respiratory health survey

    Time frame: 8 weeks

    Patients' self evaluation of COPD Assessment Test

  5. Biomarkers

    Time frame: 4 weeks

    Blood concentration of biomarkers (Inflammatory cytokines)

  6. Biomarkers

    Time frame: 8 weeks

    Blood concentration of biomarkers (Inflammatory cytokines)

  7. Heavy metals

    Time frame: 4 weeks

    Blood concentration of heavy metals

  8. Heavy metals

    Time frame: 8 weeks

    Blood concentration of heavy metals

Secondary outcomes

  1. Bronchial assessment

    Time frame: 4 weeks

    Patients' self evaluation of Bronchiectasis Health Questionnaire

  2. Bronchial assessment

    Time frame: 8 weeks

    Patients' self evaluation of Bronchiectasis Health Questionnaire

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.