UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035339 |
|---|---|
| Receipt number | R000040253 |
| Scientific Title | A clinical study to evaluate the effects of the indoor plants on recovery from fatigue |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2021/12/27 14:47:53 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040253
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| Registered date | File name |
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