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This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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™) |
|
| Placebo group | Placebo Comparator | 2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronch™ | Dietary Supplement | 2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 0, 6, 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| FVC(Forced vital capacity) | The Forced vital capacity(FVC) was measured Flow rate discharged during the hard-working unit before and after the intervention. | screening, 12 week |
| FEV1(Forced expiratory volume in 1 second) |
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Inclusion Criteria:
Exclusion Criteria:
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
Laboratory test by show the following results
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Wan Chae, Ph.D., M.D. | Contact | 82-63-259-3040 | soowan@jbnu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| placebo | Dietary Supplement | 2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week |
|
The Forced expiratory volume in 1 second(FEV1) was assessed before and after the intervention.
| screening, 12 week |