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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034284
Receipt No. R000039085
Scientific Title Evaluate changes in atopic symptoms by ingesting health food for 24 weeks
Date of disclosure of the study information 2018/09/27
Last modified on 2018/09/26

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Basic information
Public title Evaluate changes in atopic symptoms by ingesting health food for 24 weeks
Acronym Evaluate changes in atopic symptoms by ingesting health food for 24 weeks
Scientific Title Evaluate changes in atopic symptoms by ingesting health food for 24 weeks
Scientific Title:Acronym Evaluate changes in atopic symptoms by ingesting health food for 24 weeks
Region
Japan

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

Objectives
Narrative objectives1 Take healthy food for 24 weeks for subjects with non-severe atopic symptoms, and evaluate changes in inflammatory sites
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood test, VAS, visual evaluation by doctor, subjective evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Take healthy food for 24 weeks
Interventions/Control_2
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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects who suffer from mild atopic symptoms
2. Subjects with skin dryness and sensitive skin
Key exclusion criteria 1. Subject who has a history of food allergy
2. Subject who is pregnant or lactating
3. Subjects with severe symptoms of atopic dermatitis (juiced sites of inflammation or more)
4. Subjects receiving hormone replacement therapy
5. Subjects participating in other human trials within the past 4 weeks
6. Subjects who are scheduled to receive treatment that may affect inflammatory sites during the study
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatomo Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization Forest Holdings. Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 09 Month 27 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 27 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
2018 Year 09 Month 26 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039085

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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