Effects of Bronch™ on Respiratory Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Bronch™ on Respiratory Health

Conditions
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Respiratory Health

Intervention / Treatment
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* Dietary Supplement: Bronch™
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronch™ group<br>2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day, 800 mg/day as Bronch™) | Dietary Supplement: Bronch™<br>* 2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week<br>|
| Placebo Comparator: Placebo group<br>2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day) | Dietary Supplement: placebo<br>* 2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | The Forced expiratory volume in 1 second(FEV1) was assessed before and after the intervention. | screening, 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Health, Korean mint, licorice