Clinical Trial to Evaluate the Efficacy and Safety of DWKH

NCT ID: NCT05683951

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-26

Study Completion Date

2022-12-16

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DWKH

Group Type EXPERIMENTAL

DWKH

Intervention Type DRUG

Administration of DWKH three times daily

DWKH-R

Group Type ACTIVE_COMPARATOR

DWKH-R

Intervention Type DRUG

Administration of DWKH-R three times daily

PLACEBO

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of Placebo three times daily

Interventions

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DWKH

Administration of DWKH three times daily

Intervention Type DRUG

DWKH-R

Administration of DWKH-R three times daily

Intervention Type DRUG

Placebo

Administration of Placebo three times daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DWKH-302

Identifier Type: -

Identifier Source: org_study_id

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