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 |
| Protocol serial number | N/A |
| Sponsor | Kyoto University (Japan) |
| Funders | Uehara Memorial Foundation (Japan), Suzuken Memorial Foundation (Japan) |
- 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
Scientific
Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan
| Phone | +81 (0)75 753 2411 |
|---|---|
| kawax@kuhp.kyoto-u.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open label controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | The Great Cold Study 1 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Upper respiratory tract infections |
| Intervention | Gargling with tap water, gargling with diluted povidone-iodine, and usual care |
| Intervention type | Other |
| Primary outcome measure(s) |
Incidence of upper respiratory track infections (URTI). |
| Key secondary outcome measure(s) |
Severity of upper respiratory track infections (URTI). |
| Completion date | 30/04/2003 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | Healthy volunteers aged 18-65 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 30/04/2003 |
Locations
Countries of recruitment
- Japan
Study participating centre
Yoshida-Honmachi
Kyoto
606-8501
Japan
606-8501
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
