Efficacy and Safety of BRB-F-S in Mild Asthma Patients: A 12-week, randomized, double-blind, placebo-controlled pilot study
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0009251
- Lead Sponsor
- Wonkwang University Oriental Medical Hospital, Jeonju
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1) Adult men and women aged 19 to 75 years old at the time of screening test
2) A person who has two or more persistent respiratory discomfort symptoms (cough, sputum, dyspnea, or chest tightness)
3) After using bronchodilator in pulmonary function test, compared to baseline, FEV1 >12% and > 200ml increase
Or in methacholine bronchial provocation test, a person whose concentration of methacholine (PC20) that reduces FEV1 by 20% is 16 mg/mL or less.
4) ACT(Asthma Control Test) < 20
5) A person who can discontinue use of salbutamol for 6 hours prior to the screening visit
1) Smoker or past smoker with a recent smoking cessation period of less than 1 year
2) A person whose FEV1/FVC is less than 70% or FVC is less than 80% after using bronchodilator in pulmonary function test
3) A person who shows clinically significant lung disease on chest X-ray (bronchiectasis, cystic fibrosis, obstructive bronchitis, active tuberculosis, pneumothorax, emphysema, etc.)
4) A person who is contraindicated in pulmonary function tests (surgery within 3 months, respiratory infection, hemoptysis, etc.) or who are concerned about side effects caused by bronchodilators (tachycardia, arrhythmia, etc.)
5) A person who has a history of overreaction or clinically significant hypersensitivity to drugs and human body-applied test products.
6) A person who has a history of other cerebrovascular diseases, cardiovascular diseases, endocrine diseases, malignant tumors, immune system, nervous system, or biliary tract diseases and is deemed unable to participate in the research under the judgment of the person in charge of the examination.
7) A person who has been vaccinated with the COVID-19 vaccine within 8 weeks prior to the screening test or who is scheduled to be vaccinated during the period of ingestion of the human-applied test product (12 weeks)
8) A person who has received another vaccine (influenza vaccine, etc.) within 4 weeks prior to the screening test.
9) Within 4 weeks from the screening test date, a person who took medicines that may affect test results (antitussives, expectorants, steroids, antibiotics, oral asthma medications, etc.), except for inhaled drugs (short-acting beta-2 agonists: salbutamol), herbal medicines. or health functional food
10) A person who has had a change in immunotherapy within 6 months prior to the screening visit
11) A person with alcoholism, or drug abuse or dependence
12) A person with a history of gastrointestinal diseases(eg Crohn's disease, etc.) or gastrointestinal surgery(except for simple appendectomy or hernia surgery) that may affect the absorption of human-applied test products
13) A person who participated in another human body application test within three months prior to the screening test
14) A person who shows the following results in a diagnostic laboratory test;
» ALT, AST > 3 times the upper limit of the reference value range
» Serum creatinine > 2.0 mg/dl
15) Pregnant woman, lactating woman, or woman of childbearing age who does not have the will to accept adequate contraception during clinical trials (except for woman who has undergone infertility surgery)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SGRQ/BCSS
- Secondary Outcome Measures
Name Time Method lung function test;inflammatory markers