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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027509
Receipt No. R000031530
Scientific Title Intake of vegetable extract in adult male and female with feeling of fatigue Two groups parallel test.
Date of disclosure of the study information 2017/11/16
Last modified on 2018/04/25

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Basic information
Public title Intake of vegetable extract in adult male and female with feeling of fatigue Two groups parallel test.
Acronym Fatigue feeling improvement test
Scientific Title Intake of vegetable extract in adult male and female with feeling of fatigue Two groups parallel test.
Scientific Title:Acronym Fatigue feeling improvement test
Region
Japan

Condition
Condition Healthy individual.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Observe the feeling of tiredness and mood when oral intake of plant extract of maca for 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tiredness feeling before bedtime VAS (analyzed only every Thursday).
Tiredness VAS is acquired from 1 week before ingestion start until the intake end date (4th week of intake).
Key secondary outcomes Tiredness feeling before bedtime on exercise VAS.
POMS 2 (psychological state questionnaire).
Fatigue feeling upon waking VAS (Analysis only every Thursday).
Tiredness VAS is acquired from 1 week before ingestion start until the intake end date (4th week of intake).
POMS 2 is acquired on the intake start date, the second week, and the last day (the fourth week)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Capsule containing extract of plant called maca.
The daily intake was 405 mg of Maka concentrated extract (9.6 mg as the active ingredient benzyl glucosinolate).
Consume for 4 weeks.
Interventions/Control_2 Capsule containing no plant extract of maca.
Consume for 4 weeks.
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 Those who judged that a doctor is eligible as an exam participant.
Person who has chronic (routine) fatigue of the body.
Key exclusion criteria 1) Have a chronic illness.
2) Have a serious illness, are in the hospital.
3) Taking drugs related to fatigue.
4) Ingestion of a product with the concept of relieving fatigue and mental fatigue of the body as a concept.
5) Person who judged that the examining physician is inappropriate as the exam participant.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakatsu Nishikawa, M.D.,Ph.D.
Organization Mie University Hospital
Division name Clinical Research and Development Center
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Email nisikawa@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Umeda,Ph.D.
Organization KSK Laboratories,Inc.
Division name representative
Zip code
Address t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan
TEL 059-253-8091
Homepage URL
Email info@ksk-lab.co.jp

Sponsor
Institute Mie University, Graduate School of Medicine.
Institute
Department

Funding Source
Organization Research funds obtained from Kinos Co., Ltd. are received by KSK Laboratories,Inc.
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 国立大学法人三重大学 総合研究棟2

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 16 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 05 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 27 Day
Last modified on
2018 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031530

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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