Clinical Trial to Evaluate the Efficacy and Safety of DWKH

Phase 3

Completed

• Conditions: Respiratory Infection
• Interventions: Drug: DWKH; Drug: DWKH-R; Drug: Placebo

• Registration Number: NCT05683951
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

Randomized, Double-blind, Parellel, Multicenter, Active-controlled

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-26
• Study First Submitted: 2022-05-30
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-16
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-04
• Last Update Submitted: 2023-01-04
• Study First Posted: 2023-01-13
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Male and female aged between 19 and 80.
• Patients whose BSS score is over 5.

Exclusion Criteria

• Patients allergic to any ingredients of the study drugs.
• Moderate liver disease (ALT or AST > UNLx3).
• Moderate lung disease.
• Uncontrolled HTN.
• Uncontrolled DM.
• Uncontrolled thyroidism.
• Patients who is needed antibiotics during the study period.
• In the case of women, pregnant(Urine-HCG positive) or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWKH	DWKH	-
DWKH-R	DWKH-R	-
PLACEBO	Placebo	-

Primary Outcome Measures

Name	Time	Method
Bronchitis severity score (BSS)	0,4,7 days	Difference of the BSS score (0 to 4, higher score means more severe)

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of