The effects of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue --- A placebo-controlled, double-blind study

UMIN ID: UMIN000001532

Registered date:28/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Easy fatigability
• Date of first enrollment: 2008/12/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Changes in fatigue levels measured with the POMS test 4 weeks after KBKY administration.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Polyene Project, Ltd.
• Source(s) of Monetary Support: Kracie Pharma, Ltd.