Back to resultsCatechin Gargling for Influenza Infection
Primary Purpose
Influenza Infection
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
catechin extracts (health food)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Infection focused on measuring catechins, gargling, healthy volunteers
Eligibility Criteria
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
Sites / Locations
- Seirei Hamamatsu General Hospital
- White Cross Nursing Home
- Shizuoka General Hospial
Outcomes
Primary Outcome Measures
Incidence rates of influenza infection during the study
Secondary Outcome Measures
severity of symptoms including complications and hospitalization
Full Information
NCT ID
NCT00239213
First Posted
October 13, 2005
Last Updated
October 28, 2006
Sponsor
University of Shizuoka
Collaborators
Shizuoka General Hospital, Seirei Hamamatsu General Hospital, White Cross Nursing Home
1. Study Identification
Unique Protocol Identification Number
NCT00239213
Brief Title
Catechin Gargling for Influenza Infection
Official Title
A Randomized Clinical Study of Catechin Gargling Effects on the Prevention of Influenza Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Shizuoka
Collaborators
Shizuoka General Hospital, Seirei Hamamatsu General Hospital, White Cross Nursing Home
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Infection
Keywords
catechins, gargling, healthy volunteers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
catechin extracts (health food)
Primary Outcome Measure Information:
Title
Incidence rates of influenza infection during the study
Secondary Outcome Measure Information:
Title
severity of symptoms including complications and hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroshi Yamada, MD, PhD
Organizational Affiliation
University of Shizuoka
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
White Cross Nursing Home
City
Higashi Murayama
State/Province
Tokyo
ZIP/Postal Code
189-0021
Country
Japan
Facility Name
Shizuoka General Hospial
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Catechin Gargling for Influenza Infection
We'll reach out to this number within 24 hrs