Unique ID issued by UMIN | UMIN000038878 |
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Receipt number | 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 15:14:20 |
Comparative study between parallel groups with placebo for women with daily fatigue
Study for women with daily fatigue
Comparative study between parallel groups with placebo for women with daily fatigue
Study for women with daily fatigue
Japan |
Healthy Adults
Not applicable |
Others
NO
Evaluate the fatigue improvement effect of taking maca extract for 4 weeks.
Efficacy
Fatigue VAS at the beginning of the test or after ingestion of four weeks.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
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.
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.
20 | years-old | <= |
65 | years-old | > |
Female
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
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
60
1st name | Akiko |
Middle name | |
Last name | Okamura |
Healthcare Systems Co., Ltd.
Research and Development Department
105-0004
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
okamura@hc-sys.jp
1st name | Akiko |
Middle name | |
Last name | Okamura |
Healthcare Systems Co., Ltd.
Research and Development Department
105-0004
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
okamura@hc-sys.jp
Healthcare Systems Co., Ltd.
Kinos Co., LTD
Profit organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
kakehashi@hc-sys.jp
NO
2019 | Year | 12 | Month | 13 | Day |
Unpublished
Completed
2019 | Year | 12 | Month | 06 | Day |
2019 | Year | 12 | Month | 06 | Day |
2020 | Year | 01 | Month | 18 | Day |
2020 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 13 | Day |
2020 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044334
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