Clinical Trial to Evaluate the Efficacy and Safety of DWKH

January 4, 2023 updated by: Daewon Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Drug: Placebo
Administration of Placebo three times daily
Experimental: DWKH
Drug: DWKH
Administration of DWKH three times daily
Active Comparator: DWKH-R
Drug: DWKH-R
Administration of DWKH-R three times daily

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2021

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 16, 2022

Study Registration Dates

First Submitted

May 30, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Estimate)

January 13, 2023

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWKH-302

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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