| Study name |
A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts |
| Methods |
Double‐blind randomized controlled trial |
| Participants |
Key inclusion criteria:
Japanese men aged 40 to less than 70 years old Those who wake up for urination at least twice during nocturnal sleep Those who have problems with urination, e.g. urinary urgency, frequent urination, and urinary incontinence Those who are considered as appropriate for the study by the principal investigator Those whose high‐sensitivity PSA level is less than 3.0 ng/mL (40 to 65 years old) or less than 3.5 ng/mL (65 to 70 years old) at screening and examination before ingestion Those with IPSS score of less than 20 at screening and examination before ingestion and do not need the treatment If number of people who passed 6. exceed the sample size, select those who have relatively high IPSS score
Key exclusion criteria:
At least 1 previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction Currently under treatment for cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases Those who need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, overactive bladder, and urolithiasis Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" daily Currently taking medicines or herbal medicines, or both Those who are allergic to medicines and/or the test food related products Those who had participated in another clinical test for 3 months when signing the informed consent form for this trial Considered as inappropriate for this test by the principal investigator
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| Interventions |
Intervention: saw palmetto extracts containing capsule B, once a day for 12 weeks. Swallowing a capsule after breakfast with water or warm water (approximately 200 mL) without chewing. If the participant forgets to ingest the test food, they would take it as soon as they remember within the day.
Control: placebo, same posology for 12 weeks |
| Outcomes |
Primary outcomes
IPSS: assessed at 0, 4, 8, and 12 weeks after consuming
Key secondary outcomes*
1. King's Health Questionnaire (KHQ)
2. Overactive Bladder Symptom Score (OABSS)
3. Subjective symptoms
3‐1. Visual analogue scale: pleasantness of waking, sleep quality
3‐2. Diary: frequency of urination per day, frequency of urination at night
3‐3. Interview sheet: time required for urination
*1,2 Assessed at 0, 4, 8, and 12 weeks after consuming.
*3‐2 Keep it from a week before consuming to 12 weeks after consuming.
*3‐1,3‐3 Assessed at 0 and 12 weeks after consuming. |
| Starting date |
24 June 2017 |
| Contact information |
Kazuo YAMAMOTO
CEO, ORTHOMEDICO Inc.
2F Sumitomo Fudosan Korakuen Bldg., 1‐4‐1 Koishikawa, Bunkyo‐ku, Tokyo
Telephone: 03‐3818‐0610
Email: kazu@orthomedico.jp
(contacted on 30 December 2022) |
| Notes |
The description of this study is identical to the registry of Sekikawa 2020. |
