Influenza InfectionPhase 3NCT01225770
Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers
A Phase 3 study testing green tea in people with Influenza Infection, run by University of Shizuoka at 1 site in Japan.
Trial summary
Experimental and clinical studies in adults have reported that green tea catechins prevent influenza infection. In this clinical randomized study, the investigators aimed to determine the effects of gargling with green tea on the prophylaxis of influenza infection among high school teenagers. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Infection
- What is being tested?
- green tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2010to Aug 2014
- 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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged from 15 to 20 years
- obtained written informed consent from both the student and parent before participation
- possible to gargle during 90 days
- possible to fill in questionnaire
Who cannot join
- Possessing allergy to green tea
- Possessing history of influenza infection within 6 months before entering the study
- Possessing severe immune disease or whole body infection
- severe cardiac, respiratory, renal, or hepatic dysfunction
- diagnosed as inadequate to participate in the study by student doctor
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
University of Shizuoka
Shizuoka, Shizuoka
Hiroshi Yamada, MD, PhD, +81-54-264-5762, hyamada@u-shizuoka-ken.ac.jp
Keiji Matsumoto, Ms, +81-54-264-5770, d10902@u-shizuoka-ken.ac.jp
About this study
Official title: Effects of Gargling With Green Tea on Preventing Influenza Infection Among High School Students: A Randomized Clinical Study
Experimental and clinical studies in adults have reported that green tea catechins prevent influenza infection. In this clinical randomized study, the investigators aimed to determine the effects of gargling with green tea on the prophylaxis of influenza infection among high school teenagers.
Read the detailed description
Influenza infection is the principal cause of acute respiratory illnesses and occurs in epidemic or pandemic worldwide. It spreads easily among high school students and from them to the rest of the community; therefore the prevention of influenza is very important.
Experimental studies have revealed that some components of green tea can prevent influenza infection in vitro. In clinically, gargling with green tea catechins has been reported to have possibilities to preventing influenza infection in adults; however, little clinical evidence in teenagers has so far been existed. Based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of gargling with green tea in preventing influenza infection among high school students.
- Conditions
- Influenza Infection
- Being tested
- green tea
- Keywords
- green tea, gargling, prophylaxis, influenza, Respiratory Tract Infections, high school students
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green teaDietary supplement
Gargling three times daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Green tea | Experimental | Gargling with green tea Receives: Dietary Supplement: green tea |
| water | Active comparator | Gargling with water Receives: Dietary Supplement: green tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rates of influenza infection
Measured: Until 3 months gargling
Secondary outcomes (6)
severity of influenza symptoms
Measured: until 3 months gargling
influenza-free time during the study period
Measured: until 3 months gargling
incidence of complications
Measured: until 3 months gargling
incidence rates of upper respiratory tract infections
Measured: until 3 months gargling
incidence of days of absence from school
Measured: until 3 months gargling
occurrence of the adverse events
Measured: until 3 months gargling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Shizuoka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hiroshi Yamada, MD, PhD, Study chair, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225770
- Sponsor's protocol ID
- CT2010001
- Status last verified
- Feb 2013
- First submitted
- 19 Oct 2010
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ide K, Yamada H, Matsushita K, Ito M, Nojiri K, Toyoizumi K, Matsumoto K, Sameshima Y. Effects of green tea gargling on the prevention of influenza infection in high school students: a randomized controlled study. PLoS One. 2014 May 16;9(5):e96373. doi: 10.1371/journal.pone.0096373. eCollection 2014.
PubMed 24836780
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gargling With Green Tea on Preventing Influenza Infection Among High School Students: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01225770
- Acronym / sponsor ID
- CT2010001
- Conditions
- Influenza Infection
- Keywords
- green tea, gargling, prophylaxis, influenza, Respiratory Tract Infections, high school students
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- University of ShizuokaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 21 Oct 2010 (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.
Experimental and clinical studies in adults have reported that green tea catechins prevent influenza infection. In this clinical randomized study, the investigators aimed to determine the effects of gargling with green tea on the prophylaxis of influenza infection among high school teenagers.
Detailed description
Influenza infection is the principal cause of acute respiratory illnesses and occurs in epidemic or pandemic worldwide. It spreads easily among high school students and from them to the rest of the community; therefore the prevention of influenza is very important.
Experimental studies have revealed that some components of green tea can prevent influenza infection in vitro. In clinically, gargling with green tea catechins has been reported to have possibilities to preventing influenza infection in adults; however, little clinical evidence in teenagers has so far been existed. Based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of gargling with green tea in preventing influenza infection among high school students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea | Experimental | Dietary Supplement: green teaGargling with green tea |
| water | Active comparator | Dietary Supplement: green teaGargling with water |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- aged from 15 to 20 years
- obtained written informed consent from both the student and parent before participation
- possible to gargle during 90 days
- possible to fill in questionnaire
Key exclusion criteria (5 listed)
- Possessing allergy to green tea
- Possessing history of influenza infection within 6 months before entering the study
- Possessing severe immune disease or whole body infection
- severe cardiac, respiratory, renal, or hepatic dysfunction
- diagnosed as inadequate to participate in the study by student doctor
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 |
|---|---|---|
| green teaGargling three times daily for 90 days | Dietary supplement | Green tea, water |
Primary outcome
the incidence rates of influenza infection
Time frame: Until 3 months gargling
6 secondary outcomes
severity of influenza symptoms
Time frame: until 3 months gargling
influenza-free time during the study period
Time frame: until 3 months gargling
incidence of complications
Time frame: until 3 months gargling
incidence rates of upper respiratory tract infections
Time frame: until 3 months gargling
incidence of days of absence from school
Time frame: until 3 months gargling
occurrence of the adverse events
Time frame: until 3 months gargling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Derived from this study: PubMed 24836780Ide K, Yamada H, Matsushita K, Ito M, Nojiri K, Toyoizumi K, Matsumoto K, Sameshima Y. Effects of green tea gargling on the prevention of influenza infection in high school students: a randomized controlled study. PLoS One. 2014 May 16;9(5):e96373. doi: 10.1371/journal.pone.0096373. eCollection 2014.
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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
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 green tea in people with Influenza Infection, run by University of Shizuoka at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. 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 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiroshi Yamada, MD, PhD (+81-54-264-5762, hyamada@u-shizuoka-ken.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rates of influenza infection (time frame: Until 3 months gargling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225770, which also lists 1 linked publication.
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 15 Feb 2013.