UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of the intake of ONO-SR/AST on male vitality
Acronym	A study for the effect of the intake of ONO-SR/AST on male vitality
Scientific Title	A study for the effect of the intake of ONO-SR/AST on male vitality
Scientific Title:Acronym	A study for the effect of the intake of ONO-SR/AST on male vitality
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect on male vitality of ONO-SR/AST daily intake, for 12 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tests for male vitality
Key secondary outcomes

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food daily intake, for 12 weeks
Interventions/Control_2	Intake of placebo daily intake, for 12 weeks
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	35 years-old <=
Age-upper limit	65 years-old >=
Gender	Male
Key inclusion criteria	Males from 35 to 65 years of age
Key exclusion criteria	(1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects at risk of developing allergy in relation to the study. (3) Subjects taking drugs that may affect the results of the study (4) Subjects having a history of serious diseases for which medication was required (5) Subjects having a drug dependence, alcohol dependence requiring treatment or a history of serious alcohol dependence (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on the pre-treatment test. (7) Subjects who donated or transfused 200 mL or 400 mL of whole blood within 3 months before the pre-treatment test. (8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects who cannot protect contraception during the study period (11) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Yasunari Middle name Last name Noda
Organization	ONO PHARMACEUTICAL CO., LTD.
Division name	Business Design Department
Zip code	541-8564
Address	8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka
TEL	06-6263-2924
Email	ya.noda@ono.co.jp

Public contact
Name of contact person	1st name Chiharu Middle name Last name Goto
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	c.goto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joutou-machi, Maebashi-shi, Gunma, Japan
Tel	027-261-7600
Email	info@kobunaseikei.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 02 Month 14 Day
Date of IRB	2020 Year 02 Month 20 Day
Anticipated trial start date	2020 Year 06 Month 15 Day
Last follow-up date	2020 Year 10 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 12 Day
Last modified on	2021 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046498