Influenza InfectionNCT00812448
Catechin Containing Mask for the Prevention of Influenza Infection
A study testing tea catechin extracts in people with Influenza Infection, run by University of Shizuoka at 2 sites in Japan.
Trial summary
The purpose of this study is to evaluate the effects of catechin extracts containing mask on prevention of influenza infection. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Infection
- What is being tested?
- tea catechin extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesJapan
- Study dates
- Dec 2008to Nov 2009
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Possible to wearing mask for three months
- Possible to fill out a questionnaire personally
- Obtained written informed consent before participation
Who cannot join
- Possessing some infectious diseases in need of therapy
- Possessing tea or catechin allergy
- diagnosed as inadequate for other reasons to participate the study by principal investigator
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka
University of Shizuoka
Shizuoka, Shizuoka, 422-8526
About this study
Official title: The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection
The purpose of this study is to evaluate the effects of catechin extracts containing mask on prevention of influenza infection.
Read the detailed description
Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent in-vitro experimental studies have revealed that tea catechin extracts possess the effects on the prevention of influenza infection. However, a limited number of studies have been conducted on the clinical effects. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of tea catechin extracts containing mask on the prevention of influenza infection.
- Conditions
- Influenza Infection
- Being tested
- tea catechin extracts
- Keywords
- prophylaxis, influenza infection, catechins, prophylaxis of influenza infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tea catechin extractsDietary supplement
catechins are composed of tea catechin extracts available in grren tea supplements
| Study group | Role | What they receive |
|---|---|---|
| tea catechin extracts containing mask | Experimental | wearing the tea catechin extracts containing mask Receives: Dietary Supplement: tea catechin extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of influenza infection during the study
Measured: assessed at each month
Secondary outcomes (3)
the incidence rates of upper respiratory tract infections
Measured: assessed at each month
the severity of the symptoms and the duration of the cold among incident cases
Measured: assessed at each month
he incidence-free time for influenza or upper respiratory tract infections after the intervention
Measured: assessed at each month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
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
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Shizuoka
- Sponsor type
- University, hospital or other
- Collaborators
- Seirei Hamamatsu General Hospital, Hamamatsu University
- Investigators
- Hiroshi Yamada, MD,PhD, Study chair, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812448
- Sponsor's protocol ID
- CT2009001
- Other IDs
- 20-24
- Status last verified
- Nov 2009
- First submitted
- 18 Dec 2008
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection
- ClinicalTrials.gov ID
- NCT00812448
- Acronym / sponsor ID
- CT2009001
- Conditions
- Influenza Infection
- Keywords
- prophylaxis, influenza infection, catechins, prophylaxis of influenza infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of ShizuokaUniversity, hospital or other
- Collaborators
- Seirei Hamamatsu General Hospital, Hamamatsu University
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Dec 2008 (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 evaluate the effects of catechin extracts containing mask on prevention of influenza infection.
Detailed description
Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent in-vitro experimental studies have revealed that tea catechin extracts possess the effects on the prevention of influenza infection. However, a limited number of studies have been conducted on the clinical effects. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of tea catechin extracts containing mask on the prevention of influenza infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tea catechin extracts containing mask | Experimental | Dietary Supplement: tea catechin extractswearing the tea catechin extracts containing mask |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Possible to wearing mask for three months
- Possible to fill out a questionnaire personally
- Obtained written informed consent before participation
Key exclusion criteria (3 listed)
- Possessing some infectious diseases in need of therapy
- Possessing tea or catechin allergy
- diagnosed as inadequate for other reasons to participate the study by principal investigator
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 |
|---|---|---|
| tea catechin extractscatechins are composed of tea catechin extracts available in grren tea supplements | Dietary supplement | tea catechin extracts containing mask |
Primary outcome
the incidence rate of influenza infection during the study
Time frame: assessed at each month
3 secondary outcomes
the incidence rates of upper respiratory tract infections
Time frame: assessed at each month
the severity of the symptoms and the duration of the cold among incident cases
Time frame: assessed at each month
he incidence-free time for influenza or upper respiratory tract infections after the intervention
Time frame: assessed at each month
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 26 Nov 2009.
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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 study chair
University of Shizuoka
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tea catechin extracts in people with Influenza Infection, run by University of Shizuoka at 2 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 3 inclusion and 3 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 26 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
the incidence rate of influenza infection during the study (time frame: assessed at each month). 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 26 Nov 2009.