NCT03654196

A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients

A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab. in Acute Bronchitis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject

Conditions

• Acute Bronchitis

Interventions

Type	Name	Description
DRUG	HL301(Experimental)	Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]
DRUG	Umkamin(Active Comparator)	Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]

Timeline

• Start date: 2018-03-16
• Primary completion: 2018-09-21
• Completion: 2018-09-21
• First posted: 2018-08-31
• Last updated: 2019-02-12

Locations

1 site across 1 country: South Korea