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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023274
Receipt No. R000026820
Scientific Title A double-blind,randomaized,placebo-controlled clinical trial to investigate the effect of the foods containing plant extract(No.SB2805)
Date of disclosure of the study information 2016/07/22
Last modified on 2017/05/10

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Basic information
Public title A double-blind,randomaized,placebo-controlled clinical trial to investigate the effect of the foods containing plant extract(No.SB2805)
Acronym A clinical trial to investigate the effect of the foods containing plant extract
Scientific Title A double-blind,randomaized,placebo-controlled clinical trial to investigate the effect of the foods containing plant extract(No.SB2805)
Scientific Title:Acronym 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
1st name
Middle name
Last name Masayuki Sugimoto
Organization KoganeibashiSakura Clinic
Division name Doctor
Zip code
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
1st name
Middle name
Last name Takashi Sone
Organization Koganeibashi Sakura Clinic
Division name Business and Science Department
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 22 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
2016 Year 06 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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