UMIN-CTR Clinical Trial

Basic information
Public title	A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria
Acronym	A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria
Scientific Title	A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria
Scientific Title:Acronym	A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria
Region	Japan

Condition
Condition	Nocturia due to nocturnal polyuria
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and the safety of furosemide and gosha-jinki-gan for nocturia due to nocturnal polyuria
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	nocturnal urinary frequency and nocturnal polyuria index
Key secondary outcomes	safety, quality of life, serum BNP level, blood pressure, body fluid compartments

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	furosemide, peroral administration, 20mg after lunch, once per day
Interventions/Control_2	gosha-jinki-gan, peroral administration, 7.5g/day, 3 times/day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 2 or more of I-PSS nocturia score 2) 35% or more of nocturnal polyuria index 3) 50 or more of age 4) systolic blood pressure 140mmHg or more, or diastolic blood pressure 90mmHg or more, or under treatment of hypertension 5) 20pg/ml or more and less than 200 pg/ml of serum BNP level
Key exclusion criteria	1) obvious neurogenic bladder 2) severe hypertension 3) severe complications
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koji Yoshimura
Organization	Kyoto University Graduate School of Medicine
Division name	Urology
Zip code
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Koji Yoshimura
Organization	Kyoto University Graduate School of Medicine
Division name	Urology
Zip code
Address
TEL
Homepage URL
Email	ky7527@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Urology, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.wiley.com/bw/journal.asp?ref=1757-5664&site=1
Number of participants that the trial has enrolled
Results	Both furosemide and GJG significantly improved the nocturia score in the I-PSS, the I-PSS QOL score, actual nocturnal frequency and hours of undisturbed sleep compared with those at baseline. Nocturnal frequency and nocturnal urine volume were more significantly reduced by furosemide treatment than with GJG treatment. The I-PSS total score and nocturnal urine volume significantly improved only by furosemide treatment.
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	2006 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date	2006 Year 12 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry	2010 Year 12 Month 01 Day
Date trial data considered complete	2010 Year 12 Month 01 Day
Date analysis concluded	2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 09 Month 02 Day
Last modified on	2012 Year 03 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004985

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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