- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00239213
Catechin Gargling for Influenza Infection
October 28, 2006 updated by: University of Shizuoka
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shizuoka, Japan, 420-8527
- Shizuoka General Hospial
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 430-8558
- Seirei Hamamatsu General Hospital
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Tokyo
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Higashi Murayama, Tokyo, Japan, 189-0021
- White Cross Nursing Home
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy volunteers
- aged 20 to 65 years old
- obtained written informed concent before participation
- inoculated with influenza vaccine before entering the study
Exclusion Criteria:
- other gargling except water during the study
- possessing tea allergy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence rates of influenza infection during the study
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Secondary Outcome Measures
Outcome Measure |
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severity of symptoms including complications and hospitalization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hiroshi Yamada, MD, PhD, University of Shizuoka
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
October 13, 2005
First Submitted That Met QC Criteria
October 13, 2005
First Posted (Estimate)
October 14, 2005
Study Record Updates
Last Update Posted (Estimate)
October 31, 2006
Last Update Submitted That Met QC Criteria
October 28, 2006
Last Verified
October 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT2005002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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