UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035693 |
|---|---|
| Receipt number | 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 13:24:22 |
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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
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
meg-y@lion.co.jp
Sponsor or person
Institute
LION Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040639
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
