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11 February 2012 
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The randomised controlled trial to evaluate effectiveness of gargling for the prevention of upper respiratory tract infections
ISRCTN ISRCTN67680497
ClinicalTrials.gov identifier
Public title The randomised controlled trial to evaluate effectiveness of gargling for the prevention of upper respiratory tract infections
Scientific title
Acronym The Great Cold Study 1
Serial number at source N/A
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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised open label controlled trial
Countries of recruitment Japan
Disease/condition/study domain Upper respiratory tract infections
Participants - inclusion criteria Healthy volunteers aged 18-65 years
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/11/2002
Anticipated end date 30/04/2003
Status of trial Completed
Patient information material
Target number of participants 300
Interventions Gargling with tap water, gargling with diluted povidone-iodine, and usual care
Primary outcome measure(s) Incidence of upper respiratory track infections (URTI).
Secondary outcome measure(s) Severity of upper respiratory track infections (URTI).
Sources of funding 1. Uehara Memorial Foundation (Japan)
2. Suzuken Memorial Foundation (Japan)
Trial website
Publications 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
Contact name Prof  Takashi  Kawamura
  Address Yoshida-Honmachi
Sakyo-ku
  City/town Kyoto
  Zip/Postcode 606-8501
  Country Japan
  Tel +81 (0)75 753 2411
  Fax +81 (0)75 753 2424
  Email kawax@kuhp.kyoto-u.ac.jp
Sponsor Kyoto University (Japan)
  Address Yoshida-Honmachi
Sakyo-ku
  City/town Kyoto
  Zip/Postcode 606-8501
  Country Japan
  Tel +81 (0)75 753 7531
  Fax +81 (0)75 753 2091
  Email info@mail.adm.kyoto-u.ac.jp
Date applied 26/10/2004
Last edited 24/08/2009
Date ISRCTN assigned 03/11/2004
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