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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048600
Receipt No. R000055381
Scientific Title Effi cacy test of plant extract on sleep dissatisfi ed people
Date of disclosure of the study information 2022/08/05
Last modified on 2022/08/05

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Basic information
Public title Efficacy test of plant extract on sleep
Acronym Sleep test
Scientific Title Effi cacy test of plant extract on sleep dissatisfi ed people
Scientific Title:Acronym Sleep test
Region
Japan

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

Objectives
Narrative objectives1 Confi rmation of the eff ect of plant extract intake on sleep for sleep dissatisfi ed people
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Indexes on sleeping
Key secondary outcomes Indexes on sleeping
Questionnaire

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 Intake of a food containing plant extract oncea day for one weeks
Interventions/Control_2 Intake of a placebo food that does not containplant extract once a day for one weeks
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
45 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria -Healthy men and women.
-Subjects who are aware of problems or issues with sleep.
-Subjects who can make self-judgment and arevoluntarily giving written informed consent.
Key exclusion criteria -Currently receiving treatment (including medication) for any disease
-Subjects who have been diagnosed as having a sleep disorder such as insomnia or sleep apnea syndrome, and are taking drugs such as sleep inducers or insomnia medications (including OTC drugs as well as prescription drugs),or receiving treatment with CPAP or mouthpieces, etc.
-Those who regularly consume foods for specified health uses, foods with functional claims, or other foods/beverages with possible functional properties.
-Subjects with a BMI over 30 (severely obese)
-Subjects who are primarily responsible for the care of persons in need of nursing care or infants.
-All who are unable to sleep alone on a single bedding (e.g., futon or bed) during the study period.
-A person who is not able to comply with the gentle sleep control (going to bed within Plus or minus 2 hours of the reported bedtime and waking up within Plus or minus 2 hours of the reported waking time) during the test period.
-Candidates who cannot avoid drinking alcohol and consuming caffeinated beverages (sencha, black tea, coffee, caffeinated beverages, etc.) after 6:00 p.m. during the EEG measurement period and the day before the measurement period.
-Consistently consumes more than adequate alcohol (average daily alcohol consumption of approximately 20 g of pure alcohol or less).
-Consentee who is unable to complete the EEG measurement and the sleep diary/OSA sleep questionnaire according to the schedule.
-Participants who have participated or will participate in other clinical trials in the month prior to the date of consent
-Other individuals who are deemed by the physician to be inappropriate to participate in the study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yuya
Middle name
Last name Tezuka
Organization WELLPHARMA Inc.
Division name research team
Zip code 150-0002
Address Shibuya 1 and 2F, 2-4-3 Shibuya, Shibuya-ku, Tokyo, 150-0002, Japan
TEL +81-3-6868-8806
Email yuya_t@wellpharma.co.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Shimada
Organization Clinical Creative Co.,Ltd.
Division name Pharmaceuticals Division
Zip code 061-1121
Address 6-1-3 Central, Kitahiroshima City, Hokkaido, 061-1121, Japan
TEL +81-11-887-7197
Homepage URL
Email y-shimada@cli-creative.com

Sponsor
Institute WELLPHARMA Inc.
Institute
Department

Funding Source
Organization WELLPHARMA 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 Sapporo yurinokai Hospital
Address 11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel +81-11-771-1501
Email info@yurinokai.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
2022 Year 08 Month 05 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 Open public recruiting
Date of protocol fixation
2022 Year 06 Month 20 Day
Date of IRB
2022 Year 06 Month 29 Day
Anticipated trial start date
2022 Year 07 Month 07 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 05 Day
Last modified on
2022 Year 08 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055381

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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