Respiratory Health Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | April 2021 |
| Est. primary completion date | April 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Jeonju | Jeollabuk-do |
| Lead Sponsor | Collaborator |
|---|---|
| Chonbuk National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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.
| 0, 6, 12 week |
| |
| Secondary | 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 | |
| Secondary | 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 |
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|---|---|---|---|
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