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Clinical Trial to Evaluate the Efficacy and Safety of DWKH

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05683951
Enrollment
186
Registered
2023-01-13
Start date
2021-11-26
Completion date
2022-12-16
Last updated
2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infection

Brief summary

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

Interventions

DRUGDWKH

Administration of DWKH three times daily

DRUGDWKH-R

Administration of DWKH-R three times daily

DRUGPlacebo

Administration of Placebo three times daily

Sponsors

Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bronchitis severity score (BSS)0,4,7 daysDifference of the BSS score (0 to 4, higher score means more severe)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026