UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043196 |
|---|---|
| Receipt number | R000049299 |
| Scientific Title | Protective efficacy of the nose gargle for the common cold symptom |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2021/08/18 23:04:12 |
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Basic information
Public title
Protective efficacy of the nose gargle for the common cold symptom
Acronym
Protective efficacy of the nose gargle for the common cold symptom
Scientific Title
Protective efficacy of the nose gargle for the common cold symptom
Scientific Title:Acronym
Protective efficacy of the nose gargle for the common cold symptom
Region
| Japan |
Condition
Condition
common cold symptom
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Protective efficacy of the nose gargle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
three months later nose gargle start
The number of patients that had a cold
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
For three months, they do a nose gargle in 120 ml of 0.9% saline once a day
Interventions/Control_2
For three months, they do not a nose gargle
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The voluntary participants to this study among the staffs and the Institute of associate nursing students of the Self Defense Forces Sendai Hospital in 2021 years.
Key exclusion criteria
The patients who has an upper respiratory tract disease such as acute otitis media, allergic rhinitis, sinusitis, pharyngitis, pneumonia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsugumi |
| Middle name | |
| Last name | Fukunaga |
Organization
Self-Defense Forces Sendai Hospital
Division name
clinical department
Zip code
9830041
Address
1-1, Minaminometate, Miyagino-ku, Sendai-shi
TEL
08020922779
pokethrush@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Fukunaga |
Organization
Self-Defense Forces Sendai Hospital
Division name
clinical department
Zip code
9830041
Address
1-1, Minaminometate, Miyagino-ku, Sendai-shi
TEL
08020922779
Homepage URL
pokethrush@yahoo.co.jp
Sponsor or person
Institute
Self-Defense Forces Sendai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Self-Defense Forces Sendai Hospital
Address
1-1, Minaminometate, Miyagino-ku, Sendai-shi
Tel
022311111
pokethrush@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 31 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049299
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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