A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Bronch™ on Respiratory Health
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores
时间窗: 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
时间窗: 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
次要结局
- FEV1(Forced expiratory volume in 1 second)(screening, 12 week)
- FVC(Forced vital capacity)(screening, 12 week)
研究者
Soo-Wan Chae
Principal investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital