NCT05683951

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

May 30, 2022

Last Update Submit

January 4, 2023

Conditions

Respiratory Infection

Outcome Measures

Primary Outcomes (1)

  • Bronchitis severity score (BSS)

    Difference of the BSS score (0 to 4, higher score means more severe)

    0,4,7 days

Study Arms (3)

DWKH

EXPERIMENTAL
Drug: DWKH

DWKH-R

ACTIVE COMPARATOR
Drug: DWKH-R

PLACEBO

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DWKHDRUG

Administration of DWKH three times daily

DWKH
DWKH-RDRUG

Administration of DWKH-R three times daily

DWKH-R
PlaceboDRUG

Administration of Placebo three times daily

PLACEBO

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female aged between 19 and 80.
  • Patients whose BSS score is over 5.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2022

First Posted

January 13, 2023

Study Start

November 26, 2021

Primary Completion

December 9, 2022

Study Completion

December 16, 2022

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations

KR(1)