UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033738
Receipt number R000038477
Scientific Title Systematic Review of the Functions of GABA Ingestion to Improve Sleep Quality
Date of disclosure of the study information 2018/08/13
Last modified on 2022/08/16 09:40:27

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Basic information

Public title

Systematic Review of the Functions of GABA Ingestion to Improve Sleep Quality

Acronym

SR of GABA about Sleep

Scientific Title

Systematic Review of the Functions of GABA Ingestion to Improve Sleep Quality

Scientific Title:Acronym

SR of GABA about Sleep

Region

Japan


Condition

Condition

Healthy Adult

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 Function of GABA ingestion to improve sleeping quality in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

EEG during sleep

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy Adult

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

150002

Address

Shibuya-Hikarie, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan

TEL

03-3400-3200

Email

rctjapan81@gmail.com


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

1500002

Address

Shibuya-Hikarie, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan

TEL

03-3400-3200

Homepage URL


Email

rctjapan81@gmail.com


Sponsor or person

Institute

RCT Japan Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Sanwa Shurui Co.,ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

RCT Japan Co., Ltd.

Address

Shibuya-Hikarie, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan

Tel

03-3400-3200

Email

rctjapan81@gmail.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



Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 13 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

Main results already published

Date of protocol fixation

2018 Year 08 Month 01 Day

Date of IRB

2018 Year 08 Month 01 Day

Anticipated trial start date

2018 Year 08 Month 13 Day

Last follow-up date

2018 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Condition of Systematic Review

DataBase : Pubmed, J-Dream3 etc

Key Word : GABA, Sleep


Management information

Registered date

2018 Year 08 Month 13 Day

Last modified on

2022 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038477


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name