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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025094
Receipt No. R000028855
Scientific Title The effect of honeybee-collected pollen lump extract on lower urinary tract symptoms with benign prostatic enlargement - A double-blind, placebo-controlled clinical trial -
Date of disclosure of the study information 2016/12/24
Last modified on 2016/11/30

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Basic information
Public title The effect of honeybee-collected pollen lump extract on lower urinary tract symptoms with benign prostatic enlargement - A double-blind, placebo-controlled clinical trial -
Acronym The effect of honeybee-collected pollen lump extract on lower urinary tract symptoms with benign prostatic enlargement
Scientific Title The effect of honeybee-collected pollen lump extract on lower urinary tract symptoms with benign prostatic enlargement - A double-blind, placebo-controlled clinical trial -
Scientific Title:Acronym The effect of honeybee-collected pollen lump extract on lower urinary tract symptoms with benign prostatic enlargement
Region
Japan

Condition
Condition benign prostatic enlargement
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of honeybee-collected pollen lump extract on lower urinary tract symptoms with benign prostatic enlargement - A double-blind, placebo-controlled clinical trial -
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes the change of international prostatic symptoms score before and after feeding of honeybee-collected pollen lump extract
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 the feeding of honeybee-collected pollen lump extract
Interventions/Control_2 the feeding of the placebo food
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
40 years-old <=
Age-upper limit
120 years-old >=
Gender Male
Key inclusion criteria treatment naive out patients n with total International Prostate Symptom Score (IPSS) more than 4 and < 12.
Key exclusion criteria Patients were excluded if they had neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection: had severe cardiac disease, renal dysfunction (serum creatinine levels more than 2 mg/dL), and hepatic dysfunction (aspartate and alanine aminotransferase concentrations more than twice the normal values).
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 65 tsurumai, Showa-ku, Nagoya, JAPAN
TEL +81-52-744-2985
Email yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 65 tsurumai, Showa-ku, Nagoya, JAPAN
TEL +81-52-744-2985
Homepage URL
Email yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yamada Bee Farm company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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 名古屋大学医学部附属病院 泌尿器科

Other administrative information
Date of disclosure of the study information
2016 Year 12 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2016 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028855

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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