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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007232
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Workshop of urinary tract infection
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008520

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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