UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007232 |
|---|---|
| Receipt number | R000008520 |
| Scientific Title | A randomized clinical trial to evaluate the preventive effect of cranberry juice (UR65) for patients with recurrent urinary tract infection |
| Date of disclosure of the study information | 2012/02/06 |
| Last modified on | 2012/02/06 16:34:20 |
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Basic information
Public title
A randomized clinical trial to evaluate the preventive effect of cranberry juice (UR65) for patients with recurrent urinary tract infection
Acronym
The preventive effect of cranberry juice for patients with recurrent UTI
Scientific Title
A randomized clinical trial to evaluate the preventive effect of cranberry juice (UR65) for patients with recurrent urinary tract infection
Scientific Title:Acronym
The preventive effect of cranberry juice for patients with recurrent UTI
Region
| Japan |
Condition
Condition
Urinary tract infection
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the recurrent rate in a randomized clinical trial for the patients with recurrent urinary tract infection with cranberry juice(UR65)or placebo
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrent rate of urinary tract infection
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects receive cranberry juice(UR65;125ml)once a day for 24weeks.
Interventions/Control_2
The subjects receive placebo beverage once a day for 24weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with recurrent urinary tract infection including the patients with treatment completely,age from 20 to 79 year-old,outpatient clinic
Key exclusion criteria
The patients with urinary catheter indwelling,concomitant urethritis,prostatitis or epididymitis,urinary tract stone disease,urinary tract malignant disease,urinary obstruction,systemic severe condetion or other complications
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Matsumoto |
Organization
University of Occupational and Environmental Healht
Division name
Department of Urology
Zip code
Address
1-1,Iseigaoka,Yahata-nish-ku,kitakyushu,fukuoka,807-8555 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Hamasuna |
Organization
NPO"CREC net"
Division name
Secretariat
Zip code
Address
3-8-1,hananoji,wakamatuku,kitakyushu,fukuoka,808-0136 Japan
TEL
(093)741-5887
Homepage URL
Sponsor or person
Institute
Workshop of urinary tract infection
Institute
Department
Personal name
Funding Source
Organization
NISSIN Science incorporated company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
KIKKOMAN CORPORATION
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
西野クリニック（岐阜県）、石山泌尿器科皮膚科（岐阜県）、岐阜泌尿器科（岐阜県）、土井クリニック（岐阜県）、彦坂病院（兵庫県）、中野泌尿器科（兵庫県）、細部医院（東京都）、福山泌尿器科病院（福岡県）、かじクリニック（福岡県）、加野病院（福岡県）、黒住泌尿器科医院（福岡県）、高山病院（福岡県）、西南泌尿器科クリニック（福岡県）、泌尿器科・皮フ科かわの医院（福岡県）泌尿器科いとうクリニック（福岡県）、山元泌尿器科医院（福岡県）、かわい泌尿器科クリニック（福岡県）、山口皮フ泌尿器科医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 06 | 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
| 2007 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | 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
| 2012 | Year | 02 | Month | 06 | Day |
Last modified on
| 2012 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008520
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