UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047139 |
|---|---|
| Receipt number | R000053771 |
| Scientific Title | Efficacy test of plant extract on sleep dissatisfied people |
| Date of disclosure of the study information | 2022/03/10 |
| Last modified on | 2022/03/11 08:27:58 |
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Basic information
Public title
Efficacy test of plant extract on sleep
Acronym
Sleep test
Scientific Title
Efficacy test of plant extract on sleep dissatisfied people
Scientific Title:Acronym
Sleep test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the effect of plant extract intake on sleep for sleep dissatisfied people
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG during sleep 1 and 2 weeks after the start of intake of plant extract
Key secondary outcomes
Subjective assessment 1 and 2 weeks after the start of intake of plant extract
Base
Study type
Interventional
Study design
Basic design
Parallel
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 once a day for 2 consecutive weeks
Interventions/Control_2
Intake of a placebo food that does not contain plant extract once a day for 2 consecutive 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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women
Key exclusion criteria
1. Volunteers who have been diagnosed and treated for sleep disorders such as insomnia and sleep apnea syndrome
2. Volunteers taking medications that may affect this study (hypnotics, antipsychotics, anxiolytics, antidepressants, etc.)
3. Volunteers who habitually consume 180ml (sake) or more of alcohol once a week
4. Volunteers who drink more than 3 cups of coffee a day, those who cannot limit coffee intake during the test period to less than 1 cup a day
5. Others who are judged by a doctor to be inappropriate for participating in this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yanagisawa |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL
+81-029-853-3301
yanagisawa.masa.fu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Fukusumi |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL
+81-029-853-2786
Homepage URL
fukusumi.shoji.fw@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-03-5297-5548
IRB@cpcc.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
| 2022 | Year | 03 | Month | 10 | 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
| 2021 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 21 | 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 | 03 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053771
