Respiratory Conditions Due to Unspecified External AgentNCT04340375
Anti-pollution Effects of AP Green Tea Extracts
A study testing AP green tea extracts in people with Respiratory Conditions Due to Unspecified External Agent, run by Amorepacific Corporation at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Conditions Due to Unspecified External Agent
- What is being tested?
- AP green tea extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 May 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- AP green tea extracts
- Keywords
- Anti-pollution, green tea extracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP green tea extractsDietary supplement
AP green tea extracts
| Study group | Role | What they receive |
|---|---|---|
| AP green tea extracts | Experimental | 8 weeks Receives: Dietary Supplement: AP green tea extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test
Improvement in pulmonary function test
Measured: 4 weeks
Pulmonary function test
Improvement in pulmonary function test
Measured: 8 weeks
Respiratory health survey
Patients' self evaluation of COPD Assessment Test
Measured: 4 weeks
Respiratory health survey
Patients' self evaluation of COPD Assessment Test
Measured: 8 weeks
Biomarkers
Blood concentration of biomarkers (Inflammatory cytokines)
Measured: 4 weeks
Biomarkers
Blood concentration of biomarkers (Inflammatory cytokines)
Measured: 8 weeks
Heavy metals
Blood concentration of heavy metals
Measured: 4 weeks
Heavy metals
Blood concentration of heavy metals
Measured: 8 weeks
Secondary outcomes (2)
Bronchial assessment
Patients' self evaluation of Bronchiectasis Health Questionnaire
Measured: 4 weeks
Bronchial assessment
Patients' self evaluation of Bronchiectasis Health Questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start3 May 2019
- Primary completion28 Feb 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Conditions Due to Unspecified External AgentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340375
- Sponsor's protocol ID
- AP-R-2018-01
- Status last verified
- May 2020
- First submitted
- 31 Mar 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04340375
- Acronym / sponsor ID
- AP-R-2018-01
- Keywords
- Anti-pollution, green tea extracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AP green tea extracts | Experimental | Dietary Supplement: AP green tea extracts8 weeks |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP green tea extractsAP green tea extracts | Dietary supplement | AP green tea extracts |
Primary outcome
Pulmonary function test
Time frame: 4 weeks
Improvement in pulmonary function test
Pulmonary function test
Time frame: 8 weeks
Improvement in pulmonary function test
Respiratory health survey
Time frame: 4 weeks
Patients' self evaluation of COPD Assessment Test
Respiratory health survey
Time frame: 8 weeks
Patients' self evaluation of COPD Assessment Test
Biomarkers
Time frame: 4 weeks
Blood concentration of biomarkers (Inflammatory cytokines)
Biomarkers
Time frame: 8 weeks
Blood concentration of biomarkers (Inflammatory cytokines)
Heavy metals
Time frame: 4 weeks
Blood concentration of heavy metals
Heavy metals
Time frame: 8 weeks
Blood concentration of heavy metals
2 secondary outcomes
Bronchial assessment
Time frame: 4 weeks
Bronchial assessment
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AP green tea extracts in people with Respiratory Conditions Due to Unspecified External Agent, run by Amorepacific Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (time frame: 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.