None listed
Conditions
Interventions
Oral intake of the test food (2 pills in a day
8 weeks).
Oral intake of the placebo food (2 pills in a day
8 weeks).
Sponsors
Medical Corporation Seishukai Hasegawa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 40-64 years. 2) Individuals who are healthy and don't receive treatment. 3) Individuals whose urinary frequencies in the daytime are 8-10 times. 4) Individuals who wake up to urinate 0 to 1 times in a day from the time they go to bed at night to the time they wake up in the morning 5) Individuals whose written informed consent has been obtained. 6) Individuals judged appropriate for the trial by the principal.
Exclusion criteria
Exclusion criteria: 1)Individuals who are currently suffering from some kind of disease and undergoing drug treatment. And individuals who regularly use pharmaceuticals or quasi-drugs for purposes other than disease treatment. 2)Individuals who are suffering from, are undergoing treatment for, or have a history of serious diseases such as diabetes, kidney disease, heart disease, thyroid disease, adrenal gland disease, or other metabolic diseases. 3)Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. 4)Individuals who have a history of digestive system disease. 5)Individuals whose PSA level is over 4.0 ng/m. 6)Individuals with nocturia, benign prostatic hyperplasia, or overactive bladder. 7)Individuals who meet the following criteria on the Overactive Bladder Symptom Questionnaire: I.Diagnostic criteria for overactive bladder Individuals who have a urinary urgency score of 2 points or more, and an OABSS total score of 3 points or more and who may have overactive bladder. II.Determination of severity of overactive bladder Individuals with OABSS total score of 6 points or more. 8)Individuals who used a drug to treat a disease in the past 1 month. 9)Individuals whose BMI is over 30. 10)Individuals who are sensitive to a test product or other foods, and medical products. 11)Individuals who have a habit of continuously taking functional foods, health foods, or supplements that claim urinary-related indicators in the past month, or who plan to take them during the study period. 12)Individuals whose life style will change during the test period. 13)Individuals who are pregnant, nursing or possibly pregnant. 14)Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. 15)Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. 16)Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes for urination | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary outcomes 1) Overactive Bladder-questionnaire (1) 2) King's Health Questionnaire (1) * Safety 1) Blood pressure, pulsation (1) 2) Weight, body fat percentage, BMI (1) 3) Hematologic test (1) 4) Blood biochemical test (1) 5) Urine analysis (1) 6) Doctor's questions (1) 7) Subject's diary (2) (1): Week 0, Week 8 (2): Recording all days from the designated day to the end of the test. | — |
Countries
Japan
Contacts
Public ContactKoichi Sudo
Medical Corporation Seishukai Hasegawa Hospital Clinical trial office
Outcome results
None listed