UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048600 |
|---|---|
| Receipt number | 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 | 2023/01/06 18:15:54 |
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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
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
y-shimada@cli-creative.com
Sponsor or person
Institute
WELLPHARMA Inc.
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055381
