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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029700
Receipt No. 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

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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
Email 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
Email matayoshi@okinawa-tlo.com

Sponsor
Institute Medical Corporation Kenshokai
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033875

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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