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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030339
Receipt No. R000034623
Scientific Title Development of effective candy which blended Lindera umbellata extract for prophylaxis of influenza virus infections.
Date of disclosure of the study information 2017/12/11
Last modified on 2018/06/21

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Basic information
Public title Development of effective candy which blended Lindera umbellata extract for prophylaxis of influenza virus infections.
Acronym Development of effective candy which blended Lindera umbellata extract for prophylaxis of influenza virus infections.
Scientific Title Development of effective candy which blended Lindera umbellata extract for prophylaxis of influenza virus infections.
Scientific Title:Acronym Development of effective candy which blended Lindera umbellata extract for prophylaxis of influenza virus infections.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the effect of the intake of candy which blended Lindera umbellata extract for 12 weeks on prophylaxis of influenza virus infections in healthy nurses (male and female).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes questionnaire survey (whether a subject caught influenza or not.)
Key secondary outcomes questionnaire survey (whether a subject caught a cold (coughing, sneezing, runny nose) or not)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test products (12weeks)
Interventions/Control_2 Oral ingestion of the control products (12weeks)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Nurses who works at Ehime University Hospital and had received influenza vaccine
Key exclusion criteria Individuals who receive treatment of infection
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiya Igase
Organization Ehime University Graduate School of Medicine
Division name Department of Geriatrics and Neurology
Zip code
Address 454 Shizukawa, Toon, Ehime
TEL 089-960-5851
Email migase@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiya Igase
Organization Ehime University Graduate School of Medicine
Division name Department of Geriatrics and Neurology
Zip code
Address 454 Shizukawa, Toon, Ehime
TEL 089-960-5851
Homepage URL
Email migase@m.ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 11 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 Completed
Date of protocol fixation
2017 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 11 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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