UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051771 |
|---|---|
| Receipt number | R000059086 |
| Scientific Title | Systematic Review of the Effect of a Gamma-Amino Butyric Acid for Improvement of Sleep, Stress and Blood Pressure Function. |
| Date of disclosure of the study information | 2023/08/03 |
| Last modified on | 2023/10/04 15:08:20 |
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Basic information
Public title
Systematic Review of the Effect of a Gamma-Amino Butyric Acid for Improvement of Sleep, Stress and Blood Pressure Function.
Acronym
SR of GABA for Improvement of Sleep, Stress and Blood Pressure Function.
Scientific Title
Systematic Review of the Effect of a Gamma-Amino Butyric Acid for Improvement of Sleep, Stress and Blood Pressure Function.
Scientific Title:Acronym
SR of GABA for Improvement of Sleep, Stress and Blood Pressure Function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of intake of GABA on sleep, stress and blood pressure in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of sleep, stress, and blood pressure
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Sick Person, Pregnant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Key |
| Middle name | |
| Last name | Mochida |
Organization
RCT Japan Co., Ltd.
Division name
R&D
Zip code
150-0002
Address
Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
TEL
03-3400-3200
info@rctjapan.org
Public contact
Name of contact person
| 1st name | Key |
| Middle name | |
| Last name | Mochida |
Organization
RCT Japan Co., Ltd.
Division name
R&D
Zip code
150-0002
Address
Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
TEL
03-3400-3200
Homepage URL
info@rctjapan.org
Sponsor or person
Institute
Kino-Ken
Institute
Department
Personal name
Funding Source
Organization
RCT Japan 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
RCT Japan Co., Ltd.
Address
Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
Tel
03-3400-3200
info@rctjapan.org
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
| 2023 | Year | 08 | Month | 03 | 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
| 2023 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Key words: GABA, quality of sleep, stress, blood pressure
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059086
