Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis
Status:
Unknown status
Trial end date:
2020-03-01
Target enrollment:
Participant gender:
Summary
This study is a phase 2, multicentre, dose-finding, double-blind, randomized
placebo-controlled trial to evaluate the efficacy and safety of two different doses of GHX02,
compared with placebo, for acute bronchitis. One-hundred and fifty patients will be included
in this trial and randomly assigned to either a high-dose GHX02 group(1920mg/day),
standard-dose GHX02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio.
Patients will take one of the medications three times a day for 7 days, with 3 visiting
days(screening, day0, day7). On the screening day, the Korean Standard Tool of Pattern
Identification of Cough and Sputum, a diagnostic system that determines therapy in
Traditional Korean Medicine, will be used to allocate patients into three groups of
wind-heat, wind-cold or others.