NCT03310385

Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis: a Phase 2, Double-blind, Randomized Placebo-controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Daejeon University · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Bronchitis

Interventions

Type	Name	Description
DRUG	GHX02	Herbal medicine originating from gualouhengryunhwan
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2019-03-18
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2017-10-16
• Last updated: 2019-03-05

Locations

1 site across 1 country: South Korea