Clinical Trial to Evaluate the Efficacy and Safety of DWKH | NCT05683951

Studies
Clinical Trial to Evaluate the Efficacy and Safety of DWKH

NCT05683951

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jan 13, 2023Actual

Enrollment

186Actual

Phase

Phase 3

Conditions

Respiratory Infection

Interventions

DWKH
DWKH-R
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2021Actual

Primary Completion Date

Dec 9, 2022Actual

Completion Date

Dec 16, 2022Actual

First Submitted Date

May 30, 2022

First Submission Date that Met QC Criteria

Jan 4, 2023

First Posted Date

Jan 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2023

Last Update Posted Date

Jan 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
DWKH	Experimental	Drug: DWKH
DWKH-R	Active Comparator	Drug: DWKH-R
PLACEBO	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWKH	Drug	Administration of DWKH three times daily	DWKH
DWKH-R

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital		Seoul		08308	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided