UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the effects of the indoor plants on recovery from fatigue
Acronym	A clinical study to evaluate the effects of the indoor plants on recovery from fatigue
Scientific Title	A clinical study to evaluate the effects of the indoor plants on recovery from fatigue
Scientific Title:Acronym	A clinical study to evaluate the effects of the indoor plants on recovery from fatigue
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of the indoor plants on recovery from eyestrain and integral fatigue associated with VDT operation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Work performance evaluation (ATMT ABC task)
Key secondary outcomes	VAS (eyestrain, integral fatigue sensation, comfortable feeling), Jikaku-sho shirabe, autonomic nervous function evaluation, flicker test, urinalysis (VMA, HVA)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Rest in the room with the indoor plants for 60 min between two times VDT operations for 120 min -> washout period (1 week) -> Rest in the room without the indoor plants for 60 min between two times VDT operations for 120 min
Interventions/Control_2	Rest in the room without the indoor plants for 60 min between two times VDT operations for 120 min -> washout period (1 week) -> Rest in the room with the indoor plants for 60 min between two times VDT operations for 120 min
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	35 years-old <=
Age-upper limit	45 years-old >
Gender	Male
Key inclusion criteria	1)Healthy males whose age of 35 years or more and less than 45 years 2)Subjects having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria	1)Subjects who have structural ophthalmology diseases (glaucoma, cataract, color-vision deficiency, etc.) 2)Subjects who are currently taking part in another clinical study 3)Subjects deemed unsuitable by the investigator
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Nemoto
Organization	Sumitomo Forestry Co., Ltd.
Division name	Tsukuba Research Institute
Zip code	300-2646
Address	3-2, Midorigahara, Tsukuba, Ibaraki
TEL	029-847-0150
Email	NEMOTO_takaaki@star.sfc.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Sugino
Organization	Soiken Inc.
Division name	R&D Division
Zip code	560-0082
Address	Senri Life Science Center 13F,1-4-2,Shinsenre-higashimachi, Toyonaka,Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Fukuda Clinic
Address	Shin-Osaka brick building 2F, 1-6- 1 Miyahara,Yodogawa-ku, Osakai, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@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	2020 Year 01 Month 20 Day

Related information
URL releasing protocol	https://mol.medicalonline.jp/archive/search?jo=di6nihon&ye=2020&vo=26&nu=1
Publication of results	Published

Result
URL related to results and publications	https://mol.medicalonline.jp/archive/search?jo=di6nihon&ye=2020&vo=26&nu=1
Number of participants that the trial has enrolled	36
Results	https://mol.medicalonline.jp/archive/search?jo=di6nihon&ye=2020&vo=26&nu=1
Results date posted	2021 Year 12 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy males whose age of 35 years and or more and less than 45 years
Participant flow	Screening examination n=83 Enrollment n=36 Randomization n=36 Analysis n=35
Adverse events	There were no adverse events related to the test equipment.
Outcome measures	Work performance evaluation (ATMT ABC task) VAS (eyestrain, integral fatigue sensation, comfortable feeling), Jikaku-sho shirabe, autonomic nervous function evaluation, flicker test, urinalysis (VMA, HVA)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 11 Month 15 Day
Date of IRB	2018 Year 11 Month 15 Day
Anticipated trial start date	2018 Year 12 Month 22 Day
Last follow-up date	2019 Year 01 Month 19 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 02 Month 04 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 21 Day
Last modified on	2021 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040253