The randomised controlled trial to evaluate effectiveness of gargling for the prevention of upper respiratory tract infections

ISRCTN ISRCTN67680497
DOI https://doi.org/10.1186/ISRCTN67680497
Secondary identifying numbers N/A
Submission date
26/10/2004
Registration date
03/11/2004
Last edited
24/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Takashi Kawamura
Scientific

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan

Phone +81 (0)75 753 2411
Email kawax@kuhp.kyoto-u.ac.jp

Study information

Study designRandomised open label controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Scientific title
Study acronymThe Great Cold Study 1
Study objectivesGargling, especially with gargle medicine, is effective for the prevention of upper respiratory tract infections (URTIs).
The follow-up period is 60 days.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUpper respiratory tract infections
InterventionGargling with tap water, gargling with diluted povidone-iodine, and usual care
Intervention typeOther
Primary outcome measureIncidence of upper respiratory track infections (URTI).
Secondary outcome measuresSeverity of upper respiratory track infections (URTI).
Overall study start date01/11/2002
Completion date30/04/2003

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants300
Key inclusion criteriaHealthy volunteers aged 18-65 years
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2002
Date of final enrolment30/04/2003

Locations

Countries of recruitment

  • Japan

Study participating centre

Yoshida-Honmachi
Kyoto
606-8501
Japan

Sponsor information

Kyoto University (Japan)
University/education

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan

Phone +81 (0)75 753 7531
Email info@mail.adm.kyoto-u.ac.jp
ROR logo "ROR" https://ror.org/02kpeqv85

Funders

Funder type

Charity

Uehara Memorial Foundation (Japan)

No information available

Suzuken Memorial Foundation (Japan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2005 Yes No
Results article results 01/11/2007 Yes No
Results article results 16/12/2008 Yes No