Respiratory InfectionPhase 3NCT05683951
Clinical Trial to Evaluate the Efficacy and Safety of DWKH
A Phase 3 study testing DWKH and DWKH-R in people with Respiratory Infection, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Randomized, Double-blind, Parellel, Multicenter, Active-controlled Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Respiratory Infection
- What is being tested?
- DWKH and DWKH-R
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Nov 2021to 16 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female aged between 19 and 80.
- Patients whose BSS score is over 5.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH
Randomized, Double-blind, Parellel, Multicenter, Active-controlled
- Conditions
- Respiratory Infection
- Being tested
- DWKH, DWKH-R, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWKHDrug
Administration of DWKH three times daily
DWKH-RDrug
Administration of DWKH-R three times daily
PlaceboDrug
Administration of Placebo three times daily
| Study group | Role | What they receive |
|---|---|---|
| DWKH | Experimental | Not described Receives: Drug: DWKH |
| DWKH-R | Active comparator | Not described Receives: Drug: DWKH-R |
| PLACEBO | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchitis severity score (BSS)
Difference of the BSS score (0 to 4, higher score means more severe)
Measured: 0,4,7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start26 Nov 2021
- Primary completion9 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683951
- Sponsor's protocol ID
- DWKH-302
- Status last verified
- Jan 2023
- First submitted
- 30 May 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH
- ClinicalTrials.gov ID
- NCT05683951
- Acronym / sponsor ID
- DWKH-302
- Conditions
- Respiratory Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, Double-blind, Parellel, Multicenter, Active-controlled
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DWKH | Experimental | Drug: DWKH |
| DWKH-R | Active comparator | Drug: DWKH-R |
| PLACEBO | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female aged between 19 and 80.
- Patients whose BSS score is over 5.
Key exclusion criteria (8 listed)
- Patients allergic to any ingredients of the study drugs.
- Moderate liver disease (ALT or AST > UNLx3).
- Moderate lung disease.
- Uncontrolled HTN.
- Uncontrolled DM.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWKHAdministration of DWKH three times daily | Drug | DWKH |
| DWKH-RAdministration of DWKH-R three times daily | Drug | DWKH-R |
| PlaceboAdministration of Placebo three times daily | Drug | PLACEBO |
Primary outcome
Bronchitis severity score (BSS)
Time frame: 0,4,7 days
Difference of the BSS score (0 to 4, higher score means more severe)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWKH and DWKH-R in people with Respiratory Infection, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchitis severity score (BSS) (time frame: 0,4,7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.