Easy fatigability
Conditions
Interventions
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.
Sponsors
Polyene Project, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Normal volunteers of 20-50 years of age
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in fatigue levels measured with the POMS test 4 weeks after KBKY administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKei Hamazaki
Polyene Project, Ltd. Section of Clinical Application, Dept of Clinical Science
Outcome results
None listed