UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027509 |
|---|---|
| Receipt number | 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 | 2019/10/01 14:14:39 |
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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
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
info@ksk-lab.co.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine.
Institute
Department
Personal name
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
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
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
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
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031530
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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