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NCT05683951 Clinical Trial

Clinical Trial to Evaluate the Efficacy and Safety of DWKH

Respiratory Infection Clinical Trial

Official title:
Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05683951
Other study ID # DWKH-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 26, 2021
Est. completion date December 16, 2022

Study information
Verified date January 2023
Source Daewon Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date December 16, 2022
Est. primary completion date December 9, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DWKH
Administration of DWKH three times daily
• DWKH-R
Administration of DWKH-R three times daily
• Placebo
Administration of Placebo three times daily

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bronchitis severity score (BSS) Difference of the BSS score (0 to 4, higher score means more severe) 0,4,7 days
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