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OpenTrials
Completed

NCT Number: NCT05683951

Clinical Trial to Evaluate the Efficacy and Safety of DWKH

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

Completed

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Key information

Conditions

Respiratory Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Guro Hospital

Seoul, 08308, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DWKH

Drug

Administration of DWKH three times daily

DWKH-R

Drug

Administration of DWKH-R three times daily

Placebo

Drug

Administration of Placebo three times daily

Primary outcomes

  1. Bronchitis severity score (BSS)

    Time frame: 0,4,7 days

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

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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