Condition category
Respiratory
Date applied
26/10/2004
Date assigned
03/11/2004
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Takashi Kawamura

ORCID ID

Contact details

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan
+81 (0)75 753 2411
kawax@kuhp.kyoto-u.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The Great Cold Study 1

Study hypothesis

Gargling, especially with gargle medicine, is effective for the prevention of upper respiratory tract infections (URTIs).
The follow-up period is 60 days.

Ethics approval

Not provided at time of registration

Study design

Randomised open label controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Upper respiratory tract infections

Intervention

Gargling with tap water, gargling with diluted povidone-iodine, and usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of upper respiratory track infections (URTI).

Secondary outcome measures

Severity of upper respiratory track infections (URTI).

Overall trial start date

01/11/2002

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers aged 18-65 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2002

Recruitment end date

30/04/2003

Locations

Countries of recruitment

Japan

Trial participating centre

Yoshida-Honmachi
Kyoto
606-8501
Japan

Sponsor information

Organisation

Kyoto University (Japan)

Sponsor details

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan
+81 (0)75 753 7531
info@mail.adm.kyoto-u.ac.jp

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Uehara Memorial Foundation (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Suzuken Memorial Foundation (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16242593
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17878657
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19087312

Publication citations

  1. Results

    Satomura K, Kitamura T, Kawamura T, Shimbo T, Watanabe M, Kamei M, Takano Y, Tamakoshi A, , Prevention of upper respiratory tract infections by gargling: a randomized trial., Am J Prev Med, 2005, 29, 4, 302-307, doi: 10.1016/j.amepre.2005.06.013.

  2. Results

    Kitamura T, Satomura K, Kawamura T, Yamada S, Takashima K, Suganuma N, Namai H, Komura Y, , Can we prevent influenza-like illnesses by gargling?, Intern. Med., 2007, 46, 18, 1623-1624.

  3. Results

    Sakai M, Shimbo T, Omata K, Takahashi Y, Satomura K, Kitamura T, Kawamura T, Baba H, Yoshihara M, Itoh H, , Cost-effectiveness of gargling for the prevention of upper respiratory tract infections., BMC Health Serv Res, 2008, 8, 258, doi: 10.1186/1472-6963-8-258.

Additional files

Editorial Notes