Efficacy and safety of GHX02 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0003665
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 117
1) aged 19–75 years
2) BSS = 5 points at visit 2 due to acute bronchitis starting within 2 weeks before study inclusion or due to acute exacerbation of chronic bronchitis with increased respiratory symptoms for more than 2 days.
3) patients who consent to participate
1) pregnant or breast-feeding
2) treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion
3) treatment with antitussives or expectorants during the last 7 days before study inclusion
4) requiring treatment of antibiotics, bronchodilators, glucocorticoids
5) history or presence of confounding respiratory disease that may affect evaluation of the efficacy of clinical medicine (e.g. chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, pneumonia, cystic fibrosis, lung cancer, or active pulmonary tuberculosis)
6) liver or renal impairment (alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP) = 3 times the normal upper limit, or creatinine> 3.0 mg/dL at screening)
7) genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
8) history or presence of clinically relevant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, infectious disease, or malignant tumour(except where there is no recurrence for more than 5 years after surgery)
9) history of alcoholism or substance abuse
10) smokers of more than 30 years
11) disagree with contraception
12) participation in other clinical drug(medicine) trials during the last 30 days before study inclusion
13) judged by the investigators to be inappropriate for the clinical trial.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in BSS(Bronchitis Severity Score) from visit2 to visit3
- Secondary Outcome Measures
Name Time Method Change in Questionnaire of Clinical Symptoms of Cough and Sputum;Change in Leicester Cough Questionnaire-acute(LCQ-acute);Change in frequency of coughing fits;Integrative Medicine Outcome Scale(IMOS);Integrative Medicine Patient Satisfaction Scale(IMPSS);adverse effect