UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036289 |
|---|---|
| Receipt number | R000041341 |
| Scientific Title | A study on the efficacy of NM191 (developmental code) |
| Date of disclosure of the study information | 2019/03/29 |
| Last modified on | 2019/09/25 13:42:58 |
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Basic information
Public title
A study on the efficacy of NM191 (developmental code)
Acronym
A study on the efficacy of NM191 (developmental code)
Scientific Title
A study on the efficacy of NM191 (developmental code)
Scientific Title:Acronym
A study on the efficacy of NM191 (developmental code)
Region
| Japan |
Condition
Condition
Healthy adults suffer from stress
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of sleep improvement of NM191 (development code)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative evaluation of objective sleep efficiency and subjective indicators of the sleep quality with OSA sleep inventory between before and after the intervention.
Key secondary outcomes
Score on the Brief Job Stress Questionnaire, autonomic nervous index with heart rate variability, biochemical components in blood, saliva and skin surface lipid before and after the intervention
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of NM191 (development code) at bed time once a day for 4 weeks
Interventions/Control_2
Ingestion of placebo beverages at bed time once a day for 4 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females of whom the score of the Brief Job Stress Questionnaire (BJSQ) and the Athens Insomnia Scale (AIS) are above the third quartile of the total BJSQ scores and 6 points of AIS, respectively.
Key exclusion criteria
- Pregnancies and lactations
- Subjects with systemic illness
-Individuals prescribed with sleeping medicines
- Individuals who can't stop taking a large amount of coffee during the test period
- Individuals deemed inappropriate to participate in this study by the principle investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Yamamoto |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7538
yamamoto.naoki@kao.com
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Suganuma |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7538
Homepage URL
suganuma.takaya@kao.com
Sponsor or person
Institute
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.com
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（東京都、栃木県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 29 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 26 | 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 | 03 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041341
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
