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Clinical trial

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

ID
Name
DWKH-302
Description
Randomized, Double-blind, Parellel, Multicenter, Active-controlled
Trial arms
Trial start
2021-11-26
Estimated PCD
2022-12-09
Trial end
2022-12-16
Status
Completed
Phase
Early phase I
Treatment
DWKH
Administration of DWKH three times daily
Arms:
DWKH
DWKH-R
Administration of DWKH-R three times daily
Arms:
DWKH-R
Placebo
Administration of Placebo three times daily
Arms:
PLACEBO
Size
186
Primary endpoint
Bronchitis severity score (BSS)
0,4,7 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 186, 'type': 'ACTUAL'}}
Updated at
2023-01-13

1 organization

3 products

1 indication

Product
DWKH-R
Indication
Respiratory Infection
Organization
Daewon Pharmaceutical
Product
Placebo
Product
DWKH