Respiratory Health
Conditions
Keywords
Respiratory Health, Korean mint, licorice
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTBronch™
2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week
DIETARY_SUPPLEMENTplacebo
2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FVC(Forced vital capacity) | screening, 12 week | The Forced vital capacity(FVC) was measured Flow rate discharged during the hard-working unit before and after the intervention. |
| FEV1(Forced expiratory volume in 1 second) | screening, 12 week | The Forced expiratory volume in 1 second(FEV1) was assessed before and after the intervention. |
Countries
South Korea
Contacts
Primary ContactSoo Wan Chae, Ph.D., M.D.
Outcome results
None listed