UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts: a randomized double-blind, parallel-group, placebo-controlled study
Title of the study (Brief title)	A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts
Region	Japan

Condition
Condition	Healthy human
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 problems with urination
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	International Prostate Symptom Score (IPSS) *Assess 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 (VAS) Pleasantness of waking, Sleep quality 3-2. Diary A frequency of urination per day, A frequency of urination at night 3-3. Interview sheet Time required for urination *1,2 Assess 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 Assess at 0 and 12 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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test material: Saw palmetto extracts containing capsule B Dose: Take a capsule once a day Administration: Swallow a capsule after breakfast with water or warm water (approximately 200 mL) without chewing *If you forget ingestion the test food, take it as soon as you remember within the day
Interventions/Control_2	Duration: 12 weeks Test material: Placebo Dose: Take a capsule once a day Administration: Swallow a capsule after breakfast with water or warm water (approximately 200 mL) without chewing *If you forget ingestion the test food, take it as soon as you remember within the day
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	70 years-old >
Gender	Male
Key inclusion criteria	1. Japanese men who are 40 or more to less than 70 years old 2. Those who wake up for urination at least twice during nocturnal sleep 3. Those who have problems with urination, e.g. urinary urgency, frequent urination, and urinary incontinence 4. Those who are considered as appropriate for the study by the principal investigator 5. Those whose high-sensitivity PSA level is less than 3.0 ng/mL (40-65 years old) or less than 3.5 ng/ml (65-70 years old) at screening and examination before ingestion 6. Those who get less than 20 in score of IPSS at screening and examination before ingestion and do not need the treatment 7. If number of people who passed 6. exceed the sample size, select those who have relatively high score in IPSS
Key exclusion criteria	1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, overactive bladder and urolithiasis 4. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 5. Currently taking medicines and/or herbal medicines 6. Those who are allergic to medicines and/or the test food related products 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Others consider as inappropriate for this test by the principal investigator
Target sample size	40

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

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

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

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

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funｄer(s)

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) Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 19 Day
Anticipated trial start date	2017 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 23 Day
Last modified on	2018 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031969