Catechin Gargling for Influenza Infection | NCT00239213

Studies
Catechin Gargling for Influenza Infection

NCT00239213

Sponsor

University of Shizuoka

Status

Completed

Last Update Posted

Oct 31, 2006Estimated

Enrollment

400

Phase

Not Applicable

Conditions

Influenza Infection

Interventions

catechin extracts (health food)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Oct 13, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2006

Last Update Posted Date

Oct 31, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of ShizuokaOTHER

Collaborators

Name	Class
Shizuoka General Hospital	UNKNOWN
Seirei Hamamatsu General Hospital	OTHER
White Cross Nursing Home	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
catechin extracts (health food)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence rates of influenza infection during the study

Secondary Outcomes

Measure	Description	Time Frame
severity of symptoms including complications and hospitalization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Yamada, MD, PhD	University of Shizuoka	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seirei Hamamatsu General Hospital		Hamamatsu	Shizuoka	430-8558	Japan
Shizuoka General Hospial