Respiratory HealthNCT04812561
Effects of Bronch™ on Respiratory Health
A study testing Bronch™ in people with Respiratory Health, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Health
- What is being tested?
- Bronch™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2020to Apr 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-80 years at screening
- nonsmoker
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Who cannot join
- Participants with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Participants who have Body Mass Index(BMI) less than 18.5 kg/m^2 or more than 35 kg/m^2
- Participants who have taken medication or dietary supplements related to the respiratory disease within 1 months prior to screening
- Participants with a history of antipsychotic medication use within 3 months prior to the screening examination
- Participants who alcoholic or drug abuse suspected
- Participants who have participated in the other human trials within 3 months before the screening test
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- Laboratory test by show the following results
- AST, ALT > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dL
- Pregnancy or breast feeding
- Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Soo-Wan Chae, MD., PhD, 82-63-259-3040, swchae@jbctc.org
About this study
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Bronch™ on Respiratory Health
This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.
Read the detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 60 subjects were randomly divided into Bronch™ group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking one pill twice a day, in comparison with taking a placebo.
- Conditions
- Respiratory Health
- Being tested
- Bronch™, placebo
- Keywords
- Respiratory Health, Korean mint, licorice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronch™Dietary supplement
2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week
placeboDietary supplement
2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week
| Study group | Role | What they receive |
|---|---|---|
| Bronch™ group | Experimental | 2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day, 800 mg/day as Bronch™) Receives: Dietary Supplement: Bronch™ |
| Placebo group | Placebo comparator | 2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores
CAT were measured in study screening, visit 2(6 week), visit 3(12 week). CAT was developed for use as a way to assess the quality of life of COPD patients, consisting of eight items, each of which evaluates 0 to 5 points, and the sum of all eight item scores is the CAT score. The best quality of life is 0 points, and the worst is 40 points.
Measured: screening, 6, 12 week
Changes of BCSS(Breathlessness, Cough, and Sputum Scale) scores
BCSS were measured in study visit 1(0 week), visit 2(6 week), visit 3(12 week). BCSS is a scale for evaluating symptoms of Breathlessness, cough, and sputum, which is a major symptom of COPD(Chronic obstructive pulmonary disease), and symptoms of Breathlessness, cough, and sputum are evaluated in five stages.
<Breathlessness, sputum> 0: never, 1: rare, 2: occasionally, 3: often, 4: almost always <Cough> 0: never, 1: a little hard, 2: moderate extent of hard, 3: over moderate extent of hard, 4: serious hard
Measured: 0, 6, 12 week
Secondary outcomes (2)
FVC(Forced vital capacity)
The Forced vital capacity(FVC) was measured Flow rate discharged during the hard-working unit before and after the intervention.
Measured: screening, 12 week
FEV1(Forced expiratory volume in 1 second)
The Forced expiratory volume in 1 second(FEV1) was assessed before and after the intervention.
Measured: screening, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start14 Dec 2020
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812561
- Sponsor's protocol ID
- NS_Bronch_01
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Bronch™ on Respiratory Health
- ClinicalTrials.gov ID
- NCT04812561
- Acronym / sponsor ID
- NS_Bronch_01
- Conditions
- Respiratory Health
- Keywords
- Respiratory Health, Korean mint, licorice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 23 Mar 2021 (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.
This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.
Detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 60 subjects were randomly divided into Bronch™ group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking one pill twice a day, in comparison with taking a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronch™ group | Experimental | Dietary Supplement: Bronch™2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day, 800 mg/day as Bronch™) |
| Placebo group | Placebo comparator | Dietary Supplement: placebo2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19-80 years at screening
- nonsmoker
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Key exclusion criteria (11 listed)
- Participants with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Participants who have Body Mass Index(BMI) less than 18.5 kg/m^2 or more than 35 kg/m^2
- Participants who have taken medication or dietary supplements related to the respiratory disease within 1 months prior to screening
- Participants with a history of antipsychotic medication use within 3 months prior to the screening examination
- Participants who alcoholic or drug abuse suspected
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 |
|---|---|---|
| Bronch™2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week | Dietary supplement | Bronch™ group |
| placebo2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week | Dietary supplement | Placebo group |
Primary outcome
Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores
Time frame: screening, 6, 12 week
CAT were measured in study screening, visit 2(6 week), visit 3(12 week). CAT was developed for use as a way to assess the quality of life of COPD patients, consisting of eight items, each of which evaluates 0 to 5 points, and the sum of all eight item scores is the CAT score. The best quality of life is 0 points, and the worst is 40 points.
Changes of BCSS(Breathlessness, Cough, and Sputum Scale) scores
Time frame: 0, 6, 12 week
BCSS were measured in study visit 1(0 week), visit 2(6 week), visit 3(12 week). BCSS is a scale for evaluating symptoms of Breathlessness, cough, and sputum, which is a major symptom of COPD(Chronic obstructive pulmonary disease), and symptoms of Breathlessness, cough, and sputum are evaluated in five stages. <Breathlessness, sputum> 0: never, 1: rare, 2: occasionally, 3: often, 4: almost always <Cough> 0: never, 1: a little hard, 2: moderate extent of hard, 3: over moderate extent of hard, 4: serious hard
2 secondary outcomes
FVC(Forced vital capacity)
Time frame: screening, 12 week
FEV1(Forced expiratory volume in 1 second)
Time frame: screening, 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronch™ in people with Respiratory Health, run by Chonbuk National University Hospital 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 11 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: status not confirmed, as of the sponsor's last update on 23 Mar 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Wan Chae, Ph.D., M.D. (82-63-259-3040, soowan@jbnu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores (time frame: screening, 6, 12 week). The study lists 2 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 23 Mar 2021.