UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041059 |
|---|---|
| Receipt number | R000046890 |
| Scientific Title | A study for the effect of intake of ONO-SR/AST-DA on sleep |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2021/07/15 12:37:46 |
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Basic information
Public title
A study for the effect of intake of ONO-SR/AST-DA on sleep
Acronym
A study for the effect of intake of ONO-SR/AST-DA on sleep
Scientific Title
A study for the effect of intake of ONO-SR/AST-DA on sleep
Scientific Title:Acronym
A study for the effect of intake of ONO-SR/AST-DA on sleep
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on quality of sleep of ONO-SR/AST-DA daily intake, for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of sleep measured by electroencephalograph
Key secondary outcomes
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
Intake of test food daily intake, for 12 weeks
Interventions/Control_2
Intake of placebo daily intake, for 12 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age
(2) A person with a score of 6 or more on Pittsburgh Sleep Questionnaire
Key exclusion criteria
1. Subjects who are currently receiving medication, dietary guidance, or exercise therapy
2. Subjects who perform an act for the improvement of the fatigue, the quality of the sleep, and stress
3. Subjects who were under treatment or have a history of serious diseases
4. Subjects who have history of mental illness, chronic fatigue syndrome, insomnia
5. Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome
6. Subjects with nocturnal urination
7. Subjects who are likely to cause skin irritation due to electrode adhesive pads
8. Subjects who have a disease that requires constant medication, subjects with serious diseases that require medication, and subjects with a history of serious diseases
9. Subjects who perform an act for the improvement of the fatigue, the quality of the sleep and stress
10. Subjects who constantly use food richly containing involvement ingredient
11. Subjects who engage in manual labor
12. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
13. Subjects who plan to travel abroad or travel abroad during the research period, or who plan to travel on long domestic business trips or domestic trips for more than one week in a row
14. Subjects who have experienced abnormal clinical test values or cardiopulmonary function and have been judged to have problems participating in the study
15. Subjects at risk of developing allergy in relation to the study
16. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
17. Subjects who have participated in other clinical study within the last one month prior to the current study
18. Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
19. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Noda |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Business Design Department
Zip code
541-8564
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka
TEL
06-6263-2924
ya.noda@ono.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.yamamichi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical co.,ltd
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
t.saito@ttc-smo.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
| 2021 | Year | 07 | Month | 15 | 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
80
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
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046890
