Unique ID issued by UMIN | UMIN000035036 |
---|---|
Receipt number | R000039948 |
Scientific Title | A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract: a randomized double-blind, parallel-group, placebo-controlled study |
Date of disclosure of the study information | 2019/11/27 |
Last modified on | 2021/05/25 11:33:37 |
A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract: a randomized double-blind, parallel-group, placebo-controlled study
A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract
A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract: a randomized double-blind, parallel-group, placebo-controlled study
A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of the test food on urination issues
Efficacy
Confirmatory
Pragmatic
Not applicable
International Prostate Symptom Score (IPSS)
*Calculate the change between screening (before consumption) and 8 weeks after consuming
1. IPSS
2. Overactive Bladder Symptom Score (OABSS)
3. Original questionnaires (Likert scale)
4. Ultrasonography of the post-void residual volume of urine
*1,2,3 Assess these at screening (before consumption) and 4 and 8 weeks after consuming
*4 Assess at screening (before consumption) and 8 weeks after consuming
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: 8 weeks
Test material: Capsule containing saw palmetto extract
Dose: Take one capsule per day
Administration: Swallow a capsule before sleeping with water (about 200 mL) and no chewing
Duration: 8 weeks
Test material: Placebo capsule
Dose: Take one capsule per day
Administration: Swallow a capsule before sleeping with water (about 200 mL) and no chewing
40 | years-old | <= |
Not applicable |
Male
1. Healthy Japanese men who are 40 or more years old
2. Those who have nocturia at least twice
3. Those who are considered as appropriate for the study by the principal investigator
4. Those whose high-sensitivity PSA level is less than 3.0 ng/mL (40-64 years old), less than 3.5 ng/mL (65-70 years old), or less than 4.0 ng/mL (more than 70 years old) at screening (before consumption)
5. Those who have 8-19 points in the IPSS at screening (before consumption) and do not need the treatment
6. Select those who have relatively high score in the IPSS
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
4. Those who need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, overactive bladder, and urolithiasis
5. Those who use or take "Foods for Specified Health Uses" and "Foods with Function Claims" in daily
6. Currently taking medications (including herbal medicines) and dietary supplements
7. Those who are an allergic reaction to medications and/or the test food related products
8. Those who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
9. Other considerations as ineligibility to participate in the study based on the evaluation of the principal physician
40
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
BGG Japan Co., Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2019 | Year | 11 | Month | 27 | Day |
Unpublished
Published
http://www.pieronline.jp/content/article/0386-3603/48030/429
44
Sekikawa T, Kizawa Y, Li Y, Takara T. Verification study on the effects of saw palmetto fruit extract on urination issues: A randomized double-blind, parallel-group, placebo-controlled study. Jpn Pharmacol Ther. 2020; 48(3): 429-440
2021 | Year | 05 | Month | 25 | Day |
2020 | Year | 03 | Month | 30 | Day |
Refer to the paper
Refer to the paper
Refer to the paper
Refer to the paper
Undecided
To require consultation among related companies
Completed
2018 | Year | 11 | Month | 12 | Day |
2018 | Year | 11 | Month | 12 | Day |
2018 | Year | 11 | Month | 28 | Day |
2019 | Year | 04 | Month | 27 | Day |
2018 | Year | 11 | Month | 27 | Day |
2021 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039948