UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023274 |
|---|---|
| Receipt number | 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 12:46:17 |
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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
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
t.sone@kb-clinic.com
Sponsor or person
Institute
SUN BRIGHT CO.,LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
