Back to resultsClinical Trial to Evaluate the Efficacy and Safety of DWKH
Primary Purpose
Respiratory Infection
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWKH
DWKH-R
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Infection
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.
Sites / Locations
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
DWKH
DWKH-R
PLACEBO
Arm Description
Outcomes
Primary Outcome Measures
Bronchitis severity score (BSS)
Difference of the BSS score (0 to 4, higher score means more severe)
Secondary Outcome Measures
Full Information
NCT ID
NCT05683951
First Posted
May 30, 2022
Last Updated
January 4, 2023
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05683951
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of DWKH
Official Title
Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Randomized, Double-blind, Parellel, Multicenter, Active-controlled
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWKH
Arm Type
Experimental
Arm Title
DWKH-R
Arm Type
Active Comparator
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DWKH
Intervention Description
Administration of DWKH three times daily
Intervention Type
Drug
Intervention Name(s)
DWKH-R
Intervention Description
Administration of DWKH-R three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of Placebo three times daily
Primary Outcome Measure Information:
Title
Bronchitis severity score (BSS)
Description
Difference of the BSS score (0 to 4, higher score means more severe)
Time Frame
0,4,7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of DWKH
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