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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025997
Receipt No. R000029886
Scientific Title A study on the effectiveness of SRRA001(development code)
Date of disclosure of the study information 2017/02/06
Last modified on 2018/01/29

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Basic information
Public title A study on the effectiveness of SRRA001(development code)
Acronym A study on the effectiveness of SRRA001(development code)
Scientific Title A study on the effectiveness of SRRA001(development code)
Scientific Title:Acronym A study on the effectiveness of SRRA001(development code)
Region
Japan

Condition
Condition Healthy individuals with relatively-deteriorated sleep health
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effectiveness of SRRA001(development code) for improvement of sleep quality
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective and objective indicators on sleep quality before and after the intake of test foods for 8 days
Key secondary outcomes Autonomic nervous activity, physical activity and biochemical components in blood and saliva before and after the intake of test foods for 8 days

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 SRRA001(development code) ingestion
(Once a day for 8 days, before sleep onset)
(Wash out for 3 weeks)
Placebo ingestion
(Once a day for 8 days, before sleep onset)
Interventions/Control_2 Placebo ingestion
(Once a day for 8 days, before sleep onset)
(Wash out for 3 weeks)
SRRA001(development code) ingestion
(Once a day for 8 days, before sleep onset)
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
Key inclusion criteria 1.Healthy male, age >=20 and <=59 years
2.Individuals whose PSQI score is higher than average score.
Key exclusion criteria 1.Individuals attending a hospital or using medical products
2.Individuals using medical products for pollinosis
3.Individuals who have chronic illness
4.Individuals who have a history of serious disease (heart disease, kidney damage, diabetes, cancer, and so on)
5.Individuals who are sensitive to medical tapes or electrodes
6.Individuals who participate in the other examinations which have an influence on this examination
7.Individuals judged inappropriate for the study by the principal
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Murase
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7871
Email murase.takatoshi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Yamamoto
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7468
Homepage URL
Email yamamoto.yasunori@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao 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
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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 06 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 01 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 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 02 Month 03 Day
Last modified on
2018 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029886

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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