UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034109
Receipt No. R000038880
Scientific Title Effects of Food Containing Asparagus Extract (ONR-8) on sleep conditions in shift workers
Date of disclosure of the study information 2018/09/12
Last modified on 2018/09/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of Food Containing Asparagus Extract (ONR-8) on sleep conditions in shift workers
Acronym Effects of Food Containing Asparagus Extract on sleep conditions in shift workers
Scientific Title Effects of Food Containing Asparagus Extract (ONR-8) on sleep conditions in shift workers
Scientific Title:Acronym Effects of Food Containing Asparagus Extract on sleep conditions in shift workers
Region
Japan

Condition
Condition sleep disorder
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of food containing asparagus extract (ONR-8) on sleep conditions in shift workers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Quality of sleep (Pittsburgh Sleep Quality Index)
Key secondary outcomes Psychomotor Vigilance. Task(PVT)
Presenteeism (WFun)
Psychological distress (K6)
Work engagement

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake the Food containing asparagus extract once a day for 4 weeks
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 nurses who work on a two-shift system and feel sleep disorders
Key exclusion criteria workers who are in treatment of depression, sleep apnea disorders, narcolepsy, narcolepsy, etc.
workers who take antidepressant drugs or sleeping medicine
workers who live with their children below school age
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohisa Nagata
Organization University of Occupational and Environmental Health, Japan
Division name Institute of Industrial Ecological Sciences
Zip code
Address Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL 093-603-1611
Email tomohisa@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Nagata
Organization University of Occupational and Environmental Health, Japan
Division name Institute of Industrial Ecological Sciences
Zip code
Address Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL 093-603-1611
Homepage URL
Email tomohisa@med.uoeh-u.ac.jp

Sponsor
Institute Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization Otsuka Parmaceutical 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
Address
Tel
Email

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 産業医科大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 12 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
2018 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 14 Day
Last follow-up date
2018 Year 12 Month 01 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 01 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 12 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.