UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract
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
Scientific Title:Acronym	A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of the test food on urination issues
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	International Prostate Symptom Score (IPSS) *Calculate the change between screening (before consumption) and 8 weeks after consuming
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	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
Interventions/Control_2	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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Middle name Last name Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	BGG Japan Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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)

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 27 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/48030/429
Number of participants that the trial has enrolled	44
Results	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
Results date posted	2021 Year 05 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 03 Month 30 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 11 Month 12 Day
Date of IRB	2018 Year 11 Month 12 Day
Anticipated trial start date	2018 Year 11 Month 28 Day
Last follow-up date	2019 Year 04 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 27 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039948