KCT0003665Completed未知
Efficacy and safety of GHX02 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: A phase ?, randomized, double-blind, placebo-controlled, multicenter trial
Daejeon Korean Medicine Hospital of Daejeon University0 sites117 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 117
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19?(Year) to 75?(Year) (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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