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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035693
Receipt No. R000040639
Scientific Title The effects of a plant extract B on sleep.
Date of disclosure of the study information 2019/02/16
Last modified on 2019/07/31

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Basic information
Public title The effects of a plant extract B on sleep.
Acronym The effects of a plant extract B on sleep.
Scientific Title The effects of a plant extract B on sleep.
Scientific Title:Acronym The effects of a plant extract B on sleep.
Region
Japan

Condition
Condition No(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of plant extract B on sleep
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Sleep quality measured by electroencephalograph.
Key secondary outcomes -Objective and subjective measurement for sleep quality.
-Subjective measurement for daytime fatigue and stress.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 -Oral administration of food including plant extract B for 1 week.
-Washout period.
-Oral administration of food not including plant extract B for 1 week.
Interventions/Control_2 -Oral administration of food not including plant extract B for 1 week.
-Washout period.
-Oral administration of food including plant extract B for 1 week.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria -Subjects who have poor sleep quality.
Key exclusion criteria -Subjects who cannot sleep properly because of mental disorder, physical disorder or drug usage.
-Subjects who use a medicine related to sleep, fatigue or stress.
-Subjects who have disease, who have to go hospital routinely, and who have to receive medical observation.
-Subjects who are unable to comply with the alcohol limit(25g/day) during the test foods intake period.
-Subjects whose BMI is over 30.
-Subjects who are pregnant or lactating, or plan to become pregnant in the near future.
-Subjects who are participating or plan to participate in any other clinical trial taking food or medicine during the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Megumi
Middle name
Last name Aono
Organization LION Corporation
Division name Wellness research laboratories
Zip code 2560811
Address 100, Tajima, Odawara, Kanagawa
TEL 0465-49-4541
Email meg-y@lion.co.jp

Public contact
Name of contact person
1st name Megumi
Middle name
Last name Aono
Organization LION Corporation
Division name Wellness research laboratories
Zip code 2560811
Address 100, Tajima, Odawara, Kanagawa
TEL 0465-49-4541
Homepage URL
Email meg-y@lion.co.jp

Sponsor
Institute LION Corporation
Institute
Department

Funding Source
Organization LION Corporation
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 LION Corporation
Address 100, Tajima, Odawara, Kanagawa
Tel 0465-49-4541
Email meg-y@lion.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
2019 Year 02 Month 16 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 56
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
2019 Year 01 Month 25 Day
Date of IRB
2019 Year 01 Month 24 Day
Anticipated trial start date
2019 Year 01 Month 29 Day
Last follow-up date
2019 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 28 Day
Last modified on
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040639

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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