Unique ID issued by UMIN | UMIN000001532 |
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Receipt number | R000001849 |
Scientific Title | The effects of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue --- A placebo-controlled, double-blind study |
Date of disclosure of the study information | 2008/11/28 |
Last modified on | 2009/06/24 23:03:54 |
The effects of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue --- A placebo-controlled, double-blind study
The effect of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue
The effects of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue --- A placebo-controlled, double-blind study
The effect of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue
Japan |
Easy fatigability
Medicine in general |
Others
NO
To test whether the administration of Keishi-bukuryo-gan-ryo-ka-yokuinin (KBKY) ameliorates fatigue, and to measure changes in cerebral blood and in blood levels of the followings after KBKY administration (progesterone, estrogen, fatty acids, TGF-beta, herpes virus, cytokine and Brain-derived neurotrophic factor).
Efficacy
Confirmatory
Pragmatic
Phase IV
Changes in fatigue levels measured with the POMS test 4 weeks after KBKY administration.
After 4 weeks of KBKY administration, we will measure fatigue-related materials in blood, female hormones, cerebral blood flow, facial skin contents of oil and water, autonomous nervous system, and the frontal-lobe-related functions (Krepelin test and questionnaires measuring concentration, motivation, calculation (planning), and alertness); also we will check whether subjects put their houses (living rooms etc.) in order.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is considered as a block.
YES
No need to know
2
Treatment
Medicine |
Four tablets of KBKY, twice a day (8 tablets as a total), for 4 weeks; in the case of women, from the beginning of menstruation to the next menstruation.
Four placebo tablets, twice a day (8 tablets as a total), for 4 weeks; in the case of women, from the beginning of menstruation to the next menstruation.
20 | years-old | <= |
50 | years-old | > |
Male and Female
Normal volunteers of 20-50 years of age
Those who have histories of or are suffering from serious diseases or metabolic/endocrine diseases.
Those who are allergic to KBKY.
Those of frail constitution.
Menopausal women.
Those who are pregnant, lactating or planning to be pregnant.
Those who are not suitable for the study according to the doctors in charge of this trial.
80
1st name | |
Middle name | |
Last name | Kei Hamazaki |
Polyene Project, Ltd.
Section of Clinical Application, Dept of Clinical Science
Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
076-432-8760
1st name | |
Middle name | |
Last name | Kei Hamazaki |
Polyene Project, Ltd.
Section of Clinical Application, Dept of Clinical Science
Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
076-432-8760
keihama@med.u-toyama.ac.jp
Polyene Project, Ltd.
Kracie Pharma, Ltd.
Profit organization
Japan
NO
2008 | Year | 11 | Month | 28 | Day |
Unpublished
Completed
2008 | Year | 11 | Month | 06 | Day |
2008 | Year | 12 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 04 | Month | 01 | Day |
2009 | Year | 04 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2008 | Year | 11 | Month | 28 | Day |
2009 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001849
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