Effects of Bronch™ on Respiratory Health
- Conditions
- Respiratory Health
- Interventions
- Dietary Supplement: Bronch™Dietary Supplement: placebo
- Registration Number
- NCT04812561
- Lead Sponsor
- Chonbuk National University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
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Participants with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
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Participants who have Body Mass Index(BMI) less than 18.5 kg/m^2 or more than 35 kg/m^2
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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
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Participants who alcoholic or drug abuse suspected
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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
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Pregnancy or breast feeding
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Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bronch™ group 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 2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of