Healthy adult
Conditions
Interventions
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Japanese male from 30 to 80 years of age (2) Subjects who have problems with urinary voiding (urinary frequency more than 8 times during the day)
Exclusion criteria
Exclusion criteria: 1) Subjects who are judged to have overactive bladder 2) Subjects diagnosed as having benign prostatic hyperplasia. 3) Subjects with a history of prostate cancer or suspected prostate cancer 4) Subjects who have nocturia more than twice in the bladder diary before start of intake of trial supplement 5) Subjects whose PSA is 4.0 ng/mL or higher 6) Subjects who are undergoing hospitalization/treatment for dysuria, or those who have been judged to require treatments 7) Subjects who are unable to record the urine volume for a designated period 8) Subjects who have urinary tract infection, urinary tract stones, kidney stones, ureteral stones, gallstones, etc. 9) Subjects who are taking health foods, etc. that affect urination at least once a week, or those who wish to take them during the study period 10) Subjects who are currently taking medication or exercise therapy 11) Subjects who have or history diseases such as diabetes, hepatic, renal, or cardiac diseases, or diseases that affect the secretion of adrenal cortical hormones, or other metabolic diseases 12) Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease, and those who are scheduled for surgery. 13) Subjects who may develop allergies in relation to the research. 14) Subjects who have participated in other clinical trials within the past month prior to the screening test date. 15) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study 16) Subjects whose physical measurements, physical examination values, and clinical examination values were significantly out of the reference range 17) Subjects who are judged to be unsuitable as subjects based on the background survey. 18) Subjects who are judged to be unsuitable as subjects by the principal investigator or the principle investigational doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder diary (urinary frequency, urine volume) | — |
Secondary
| Measure | Time frame |
|---|---|
| OAB-q, OABSS-Bother, IPSS-Bother, Pittsburgh sleep quality index-Japanese version (PSQI-J), urinary 8-OHdG Subgroup analysis of primary and secondary outcome based on urinary frequency, nocturia, urinary 8-OHdG, or PSQI-J | — |
Countries
Japan
Contacts
Public ContactKaori Yoshimura
EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section
Outcome results
None listed