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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033946
Receipt No. R000038719
Scientific Title Reduction of fatigue caused by ingestion of Mulberry
Date of disclosure of the study information 2018/08/30
Last modified on 2018/08/29

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Basic information
Public title Reduction of fatigue caused by ingestion of Mulberry
Acronym Reduction of fatigue caused by ingestion of Mulberry
Scientific Title Reduction of fatigue caused by ingestion of Mulberry
Scientific Title:Acronym Reduction of fatigue caused by ingestion of Mulberry
Region
Japan

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

Objectives
Narrative objectives1 Evaluate whether it is effective for fatigue improvement of normal subjects by ingesting test foods.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 A test food per day for 2 weeks.
Interventions/Control_2 No intervention
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. Males and females between 20 and 59 years of age inclusive
2. Subjects who are aware of non-chronic fatigue
Key exclusion criteria 1. Subjects with food allergies
2. Subjects who are pregnant or lactating
3. Subjects who are taking medications affecting the exam
4. Subjects who are taking health foods affecting the exam
5. Subjects with chronic fatigue syndrome
6. Subjects affected by the other disease
7. Subjects who are judged as unsuitable for the study by the principal investigator for the other reason
Target sample size 20

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 0363020593
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 0363020593
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization Matsukumakogyo Co.,Ltd.
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 08 Month 30 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 07 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 30 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 08 Month 29 Day
Last modified on
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038719

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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