UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025094 |
|---|---|
| Receipt number | 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 22:51:39 |
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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
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
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028855
