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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038878
Receipt No. R000044334
Scientific Title Comparative study between parallel groups with placebo for women with daily fatigue
Date of disclosure of the study information 2019/12/13
Last modified on 2020/03/04

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Basic information
Public title Comparative study between parallel groups with placebo for women with daily fatigue
Acronym Study for women with daily fatigue
Scientific Title Comparative study between parallel groups with placebo for women with daily fatigue
Scientific Title:Acronym Study for women with daily fatigue
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the fatigue improvement effect of taking maca extract for 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fatigue VAS at the beginning of the test or after ingestion of four weeks.
Key secondary outcomes

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 Intake 2 tablets of Test food A* daily for 4 weeks.
*Test food A and B are capsules containing either placebo (dextrin 400mg) or maca extract 400mg.
Interventions/Control_2 Intake 2 tablets of Test food B* daily for 4 weeks.
*Test food A and B are capsules containing either placebo (dextrin 400mg) or maca extract 400mg.
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
65 years-old >
Gender Female
Key inclusion criteria 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who are 20 years old or more and under 65 years old
3.Persons who with chronic (daily) fatigue
4.Persons who are the top 60 of the value of Fatigue VAS at the screening
Key exclusion criteria 1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who regularly use medicines, specified insurance foods, health foods, etc. that may affect physical and mental fatigue
4.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
5.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
6.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Okamura
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email okamura@hc-sys.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Okamura
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email okamura@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Kinos 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 The Ethics Committee of Healthcare Systems Co., Ltd.
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel 03-6809-2722
Email kakehashi@hc-sys.jp

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
2019 Year 12 Month 13 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
2019 Year 12 Month 06 Day
Date of IRB
2019 Year 12 Month 06 Day
Anticipated trial start date
2020 Year 01 Month 18 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 13 Day
Last modified on
2020 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044334

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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