UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029700 |
|---|---|
| Receipt number | R000033875 |
| Scientific Title | Study on stress mitigation effect by temporary work by ingestion of moromisu or citric acid drink |
| Date of disclosure of the study information | 2017/10/30 |
| Last modified on | 2018/04/26 09:30:03 |
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Basic information
Public title
Study on stress mitigation effect by temporary work by ingestion of moromisu or citric acid drink
Acronym
Study on stress mitigation effect by temporary work by ingestion of moromisu or citric acid drink
Scientific Title
Study on stress mitigation effect by temporary work by ingestion of moromisu or citric acid drink
Scientific Title:Acronym
Study on stress mitigation effect by temporary work by ingestion of moromisu or citric acid drink
Region
| Japan |
Condition
Condition
Healthy Japanese adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the improvement of stress with intake of moromisu or citric acid
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
stress marker in saliva
Key secondary outcomes
visual analog scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 2 weeks
Test material: moromisu
Dose: 100ml per day
Interventions/Control_2
Duration: 2 weeks
Test material: citric acid drink
Dose: 100ml per day
Interventions/Control_3
Duration: 2 weeks
Test material: placebo
Dose: 100ml per day
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who are mainly employees of desk work and are feeling stress or fatigue from 20 at 65 years old
Key exclusion criteria
Person undergoing treatment for chronic diseases
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Sumio Kondo |
Organization
Medical Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
Address
2-12-13, Tamagawa Fukushima-ku, Osaka, Japan
TEL
06-6882-1130
s.kondo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Matayoshi |
Organization
Okinawa TLO Co., Ltd.
Division name
NA
Zip code
Address
Sangakukanrenkeisuisinkikou building 3F, Senbaru1, Nishihara-cho Nakagami-gun, Okinawa, Japan
TEL
098-895-1701
Homepage URL
matayoshi@okinawa-tlo.com
Sponsor or person
Institute
Medical Corporation Kenshokai
Institute
Department
Personal name
Funding Source
Organization
Okinawa TLO 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
Address
Tel
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
| 2017 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033875
