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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033437
Receipt No. R000038124
Scientific Title Comparison of physical condition before ingestion and ingestion of food containing Maca and Kura-Chai-Dum
Date of disclosure of the study information 2018/07/20
Last modified on 2018/07/18

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Basic information
Public title Comparison of physical condition before ingestion and ingestion of food containing Maca and Kura-Chai-Dum
Acronym Comparison of physical condition before ingestion and ingestion of food containing Maca and Kura-Chai-Dum
Scientific Title Comparison of physical condition before ingestion and ingestion of food containing Maca and Kura-Chai-Dum
Scientific Title:Acronym Comparison of physical condition before ingestion and ingestion of food containing Maca and Kura-Chai-Dum
Region
Japan

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

Objectives
Narrative objectives1 Evaluate the effectiveness of specimens for healthy adult men who feel declining energy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but 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 Take test foods for 12 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
69 years-old >=
Gender Male
Key inclusion criteria 1. Subject without health problems
2. Subjects who have steady partners (lovers / spouses)
3.Those who are aware of the decline of energy
Key exclusion criteria 1.Subjects taking drugs for improving sexual function
2.Health food aimed at improving sexual function, subjects taking drinks
3.Subjects with a history of food allergy
4.Subjects participating in other human trials within the past 4 weeks
Target sample size 24

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 EC STUDIO 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 07 Month 20 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 07 Month 20 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 07 Month 18 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038124

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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