UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A double-blind,randomaized,placebo-controlled clinical trial to investigate the effect of the foods containing plant extract(No.SB2805)
Title of the study (Brief title)	A clinical trial to investigate the effect of the foods containing plant extract
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect on symptoms prostate of 8week-ingestion of the foods containing plant extract
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Change from baseline of IPSS total score at 4-week and 8-week consumption
Key secondary outcomes	Change from baseline of IPSS2 score at 4-week and 8-week consumption Change from baseline of BPH Impact Index total score at 4-week and 8-week consumption Change from baseline of PSA at 8-week consumption

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing plant extract for 8 weeks
Interventions/Control_2	Food without plant extract for 8 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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	1)Subjects giving written informed consent
Key exclusion criteria	1)Subject who have serious historical disease,marked impairment,or treatment in the liver,kidney,heart,lung,gastrointestinal tract,blood,endocrine system,or metabolism system 2)Subjects who have previous medical history of drug and/or food allergy 3)Subjects who constantly use oral medicines,functional foods and/or supplements 4)Subjects who are ineligible due to physician's judgment 5)Subjects who participate in other clinical trials
Target sample size	30

Research contact person
Name of lead principal investigator	Masayuki Sugimoto
Organization	KoganeibashiSakura Clinic
Division name	Doctor
Address	2-11-25,Sakuramachi,Koganei city,Tokyo,Japan
TEL	042-382-5252
Email	info.food@kb-clinic.com

Public contact
Name of contact person	Takashi Sone
Organization	Koganeibashi Sakura Clinic
Division name	Business and Science Department
Address	2-11-25,Sakuramachi,Koganei city,Tokyo,Japan
TEL	042-382-5252
Homepage URL
Email	t.sone@kb-clinic.com

Sponsor
Institute	SUN BRIGHT CO.,LTD.
Institute
Department

Funding Source
Organization	SUN BRIGHT CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 06 Day
Anticipated trial start date	2016 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 05 Month 10 Day

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

Management information
Registered date	2016 Year 07 Month 21 Day
Last modified on	2017 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026820