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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00239213
Other study ID # CT2005002
Secondary ID
Status Completed
Phase N/A
First received October 13, 2005
Last updated October 28, 2006
Start date November 2005
Est. completion date April 2006

Study information

Verified date October 2006
Source University of Shizuoka
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
catechin extracts (health food)


Locations

Country Name City State
Japan Seirei Hamamatsu General Hospital Hamamatsu Shizuoka
Japan White Cross Nursing Home Higashi Murayama Tokyo
Japan Shizuoka General Hospial Shizuoka

Sponsors (4)

Lead Sponsor Collaborator
University of Shizuoka Seirei Hamamatsu General Hospital, Shizuoka General Hospital, White Cross Nursing Home

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence rates of influenza infection during the study
Secondary severity of symptoms including complications and hospitalization
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