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
-
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.
-
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.
-
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.