Influenza InfectionNCT00239213
Catechin Gargling for Influenza Infection
A study testing catechin extracts (health food) in people with Influenza Infection, run by University of Shizuoka at 3 sites in Japan.
Trial summary
The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Infection
- What is being tested?
- catechin extracts (health food)
- How many people
- 400 participants
- Where
- 3 sitesJapan
- Study dates
- Nov 2005to Apr 2006
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- aged 20 to 65 years old
- obtained written informed concent before participation
- inoculated with influenza vaccine before entering the study
Who cannot join
- other gargling except water during the study
- possessing tea allergy
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558
White Cross Nursing Home
Higashimurayama, Tokyo, 189-0021
Shizuoka General Hospial
Shizuoka, Shizuoka, 420-8527
About this study
Official title: A Randomized Clinical Study of Catechin Gargling Effects on the Prevention of Influenza Infection
The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.
Read the detailed description
In-vitro experimental studies have revealed that tea catechin extracts induce preventive effects on influenza infection. However, few studies have been conducted on the effects of tea gargling on influenza infection, and the clinical evidence is unclear. Also there have been no studies reported on the gargling effects with tea catechin extracts on the prevention of influenza infection.
- Conditions
- Influenza Infection
- Being tested
- catechin extracts (health food)
- Keywords
- catechins, gargling, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catechin extracts (health food)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of influenza infection during the study
Secondary outcomes (1)
severity of symptoms including complications and hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startNov 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University of Shizuoka
- Sponsor type
- University, hospital or other
- Collaborators
- Shizuoka General Hospital, Seirei Hamamatsu General Hospital, White Cross Nursing Home
- Investigators
- Hiroshi Yamada, MD, PhD, Principal investigator, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239213
- Sponsor's protocol ID
- CT2005002
- Status last verified
- Oct 2006
- First submitted
- 13 Oct 2005
- Last updated
- 31 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of Catechin Gargling Effects on the Prevention of Influenza Infection
- ClinicalTrials.gov ID
- NCT00239213
- Acronym / sponsor ID
- CT2005002
- Conditions
- Influenza Infection
- Keywords
- catechins, gargling, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- University of ShizuokaUniversity, hospital or other
- Collaborators
- Shizuoka General Hospital, Seirei Hamamatsu General Hospital, White Cross Nursing Home
- Study start
- Nov 2005
- Study completion
- Apr 2006
- First posted
- 14 Oct 2005 (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 clarify the preventive effects of catechin gargling on the influenza infection.
Detailed description
In-vitro experimental studies have revealed that tea catechin extracts induce preventive effects on influenza infection. However, few studies have been conducted on the effects of tea gargling on influenza infection, and the clinical evidence is unclear. Also there have been no studies reported on the gargling effects with tea catechin extracts on the prevention of influenza infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy volunteers
- aged 20 to 65 years old
- obtained written informed concent before participation
- inoculated with influenza vaccine before entering the study
Key exclusion criteria (2 listed)
- other gargling except water during the study
- possessing tea allergy
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 |
|---|---|---|
| catechin extracts (health food) | Drug | – |
Primary outcome
Incidence rates of influenza infection during the study
1 secondary outcome
severity of symptoms including complications and hospitalization
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 31 Oct 2006.
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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.
Hiroshi Yamada, MD, PhD principal investigator
University of Shizuoka
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catechin extracts (health food) in people with Influenza Infection, run by University of Shizuoka at 3 sites in Japan.
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 2 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 31 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Incidence rates of influenza infection during the study. 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 31 Oct 2006.