UMIN-CTR Clinical Trial

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
Email	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
Email	pokethrush@yahoo.co.jp

Sponsor
Institute	Self-Defense Forces Sendai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049299