Time point | Study period | |||
Enrolment | Allocation | Postallocation | ||
Screening | Day 0 | Day 0 | Day 7 | |
Enrolment: | ||||
Eligibility screen | X | |||
Informed consent | X | |||
Demographic data | X | |||
Vital signs | X | X | X | |
Previous History | X | |||
Concomitant medication | X | X | X | |
Physical examination and radiography | X | |||
Laboratory examination | X | X | ||
Pattern identification of cough and sputum | X | |||
Allocation | X | |||
Interventions: | ||||
High-dose GHX02 | ||||
Standard-dose GHX02 | ||||
Placebo | ||||
Assessments: | ||||
BSS | X | X | X | |
QCSCS | X | X | ||
LCQ-K-acute | X | X | ||
Frequency of cough fits | ||||
IMOS, IMPSS | X | |||
Withdrawal rate of patients with exacerbation | X | |||
Concomitant therapy | X | X | ||
Adverse events | X | X | ||
Compliance | X |
BSS, Bronchitis Severity Score; IMOS, Integrative Medicine Outcome Scale; IMPSS, Integrative Medicine Patient Satisfaction Scale; LCQ-K-acute, Leicester Cough Questionnaire-Korean version acute; QCSCS, Questionnaire on Clinical Symptoms of Cough and Sputum.