Anti-pollution Effects of AP Green Tea Extracts
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
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
March 31, 2020
CompletedFirst Posted
Study publicly available on registry
April 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedJune 16, 2021
May 1, 2020
10 months
March 31, 2020
June 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Pulmonary function test
Improvement in pulmonary function test
4 weeks
Pulmonary function test
Improvement in pulmonary function test
8 weeks
Respiratory health survey
Patients' self evaluation of COPD Assessment Test
4 weeks
Respiratory health survey
Patients' self evaluation of COPD Assessment Test
8 weeks
Biomarkers
Blood concentration of biomarkers (Inflammatory cytokines)
4 weeks
Biomarkers
Blood concentration of biomarkers (Inflammatory cytokines)
8 weeks
Heavy metals
Blood concentration of heavy metals
4 weeks
Heavy metals
Blood concentration of heavy metals
8 weeks
Secondary Outcomes (2)
Bronchial assessment
4 weeks
Bronchial assessment
8 weeks
Study Arms (1)
AP green tea extracts
EXPERIMENTAL8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Seoul Hospital
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2020
First Posted
April 9, 2020
Study Start
May 3, 2019
Primary Completion
February 28, 2020
Study Completion
April 30, 2020
Last Updated
June 16, 2021
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share