UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study on effects of improvement sexual function in male: A randomized double-blind placebo-controlled comparison trial
Title of the study (Brief title)	A verification study on effects of improvement sexual function in male
Region	Japan

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

Objectives
Narrative objectives1	To verify the effects of test food ingestion on improvement sexual function in male
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	International Index of Erectile Function (IIEF) Japanese version
Key secondary outcomes	1.Blood test High-sensitivity PSA Free testosterone 2.Mearsurement of nocturnal penile tumescence during night sleep 3.Subjects symptoms Androgen decline in the aging male questionnaire VAS (Visual Analogue Scale)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Period : 12 weeks Test materials: Pseudoginseng capsule Does: 1 capsule for once a day Administration: Take 1 capsule with water during after dinner and before going to bed *If you forget to take the capsule, take it as soon as you remember
Interventions/Control_2	Period : 12 weeks Test materials: Placebo capsule Does: 1 capsule for once a day Administration: Take 1 capsule with water during after dinner and before going to bed *If you forget to take the capsule, take it as soon as you remember
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Healthy Japanese men who feel declining in sexual functions
Key exclusion criteria	1. At least one previous medical history 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 have erectile dysfunction (ED) and under treatment of prostatic hyperplasia or have medical history 4. Currently taking medicines and/or herbal medicines, particularly using anticoagulants such as Warfarin 5. Those who eat and/or drink Food for Specified Health Uses and/or Food with Function Claims on a daily basis 6. Allergic to medicines or foods related to test foods of this trial 7. Another clinical test participant within three months before the informed consent form submission 8. Others assessed as inappropriate for this test by the doctor responsible for the test
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
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
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	SANWA INTERNATIONAL INC.
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	2016 Year 12 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 25 Day
Anticipated trial start date	2016 Year 12 Month 01 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	Published
URL releasing results
Results	Yamashita S, Shiga M, Oshima Y, Ono H, Suzuki N, Iio S, Takara T. Effects of Sanch ginseng Extract on the Sexual Function in Japanese Men-A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial-. Jpn Pharmacol Ther. 2018; 46(4): 561-580.
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2018 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028896