None listed
Conditions
Interventions
Drug : Participants will be randomly assigned to either a high-dose GHX02 group(1,920mg/day), a standard-dose GHX02 group(960mg/day), or a placebo group(control) according to a 1:1:1 allocation ratio
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in BSS(Bronchitis Severity Score) from visit2 to visit3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactYeeRan Lyu
Dunsan Korean Medicine Hospital of Daejeon University
Outcome results
None listed