Upper Respiratory Tract InfectionsPhase 3ESYUINCT01019889
Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
A Phase 3 study testing SCRT and YPS in people with Upper Respiratory Tract Infections, run by Korea Health Industry Development Institute.
Trial summary
The purpose of this study is to determine whether Socheongryong-tang (SCRT) and Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- SCRT and YPS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jul 2009
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18~60 years old
- Clinical diagnosis of common cold
- Occurring no longer than 48 hours before enrollment
- Presented with runny nose, sore throat, plugged nose, scratchy throat, cough, hoarseness, headache, muscle ache (runny nose, sore throat and at least 1 of others or 1 of runny nose, sore throat and at least 3 of others)
Who cannot join
- Allergic rhinitis, asthma, COPD, sinusitis (2 and more recurrence per year), septal deviation, anatomical otitis media, exudative pharyngitis
- Received antihistamines, NSAIDs, corticosteroids, antibiotics, decongestants
- Hepatic cancer, liver cirrhosis, renal failure, congestive heart failure
- Pregnant or lactation
About this study
The purpose of this study is to determine whether Socheongryong-tang (SCRT) and Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.
Read the detailed description
Upper respiratory tract infections (URTIs) are the most prevalent disease of human beings, it incur a significant health burden on populations in terms of human suffering and economic losses. Usually, antibiotic therapy is not helpful since most infections are virally induced. Over 200 serologically different viral types are responsible for human URTIs, so that preventions of URTIs including vaccination are impassable. SCRT and YPS are widely used to treat the respiratory disease. The objective of this study is to determine the efficacy of SCRT and YPS in symptomatic relief of patients with URTIs.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- SCRT, YPS, Placebo
- Keywords
- upper respiratory tract infections, herbal medicine
- 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.
SCRTDrug
Also called Xiao-qing-long-tang
4 capsules,three times daily, for 7days or within symptom disappearance
YPSDrug
Also called Lian-qiao-bai-du-san
4 capsules, three times daily, for 7days or within symptom disappearance
PlaceboDrug
4 capsules, three times daily, for 7days or within symptom disappearance
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo (encapsulated starch + lactose) Receives: Drug: Placebo |
| SCRT(Socheongryong-tang ) | Experimental | encapsulated Socheongryong-tang extract Receives: Drug: SCRT |
| YPS (Yeongyopaedok-san) | Experimental | Encapsulated Yeongyopaedok-san extract Receives: Drug: YPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of score daily measured by WURSS-K before, during and after treatment
Measured: daily (7 days)
Secondary outcomes (2)
Time of symptom disappearance
Measured: daily
Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification
Measured: daily (7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Health Industry Development Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yang Chun Park, Korea Health Industry Development Institute
- Investigators
- YangChun Park, Ph. D., Principal investigator, Daejeon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019889
- Sponsor's protocol ID
- B070029
- Acronym
- ESYUI
- Status last verified
- Apr 2012
- First submitted
- 23 Nov 2009
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT01019889
- Acronym / sponsor ID
- ESYUI / B070029
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- upper respiratory tract infections, herbal medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Korea Health Industry Development InstituteOther government
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Nov 2009 (estimated)
- 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.
The purpose of this study is to determine whether Socheongryong-tang (SCRT) and Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.
Detailed description
Upper respiratory tract infections (URTIs) are the most prevalent disease of human beings, it incur a significant health burden on populations in terms of human suffering and economic losses. Usually, antibiotic therapy is not helpful since most infections are virally induced. Over 200 serologically different viral types are responsible for human URTIs, so that preventions of URTIs including vaccination are impassable. SCRT and YPS are widely used to treat the respiratory disease. The objective of this study is to determine the efficacy of SCRT and YPS in symptomatic relief of patients with URTIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboPlacebo (encapsulated starch + lactose) |
| SCRT(Socheongryong-tang ) | Experimental | Drug: SCRTencapsulated Socheongryong-tang extract |
| YPS (Yeongyopaedok-san) | Experimental | Drug: YPSEncapsulated Yeongyopaedok-san extract |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18~60 years old
- Clinical diagnosis of common cold
- Occurring no longer than 48 hours before enrollment
- Presented with runny nose, sore throat, plugged nose, scratchy throat, cough, hoarseness, headache, muscle ache (runny nose, sore throat and at least 1 of others or 1 of runny nose, sore throat and at least 3 of others)
Key exclusion criteria (4 listed)
- Allergic rhinitis, asthma, COPD, sinusitis (2 and more recurrence per year), septal deviation, anatomical otitis media, exudative pharyngitis
- Received antihistamines, NSAIDs, corticosteroids, antibiotics, decongestants
- Hepatic cancer, liver cirrhosis, renal failure, congestive heart failure
- Pregnant or lactation
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 |
|---|---|---|
| SCRTAlso: Xiao-qing-long-tang4 capsules,three times daily, for 7days or within symptom disappearance | Drug | SCRT(Socheongryong-tang ) |
| YPSAlso: Lian-qiao-bai-du-san4 capsules, three times daily, for 7days or within symptom disappearance | Drug | YPS (Yeongyopaedok-san) |
| Placebo4 capsules, three times daily, for 7days or within symptom disappearance | Drug | Placebo |
Primary outcome
Changes of score daily measured by WURSS-K before, during and after treatment
Time frame: daily (7 days)
2 secondary outcomes
Time of symptom disappearance
Time frame: daily
Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification
Time frame: daily (7days)
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 6 Apr 2012.
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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.
YangChun Park, Ph. D. principal investigator
Daejeon University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCRT and YPS in people with Upper Respiratory Tract Infections, run by Korea Health Industry Development Institute.
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 4 inclusion and 4 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 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Changes of score daily measured by WURSS-K before, during and after treatment (time frame: daily (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 6 Apr 2012.