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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004153 |
Receipt No. | R000004985 |
Scientific Title | A Crossover trial of Furosemide versus Gosha-Jinki-Gan for Nocturnal Polyuria |
Date of disclosure of the study information | 2010/09/10 |
Last modified on | 2012/03/05 |
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 |
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Condition | ||
Condition | Nocturia due to nocturnal polyuria | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1) obvious neurogenic bladder
2) severe hypertension 3) severe complications |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyoto University Graduate School of Medicine | ||||||
Division name | Urology | ||||||
Zip code | |||||||
Address | 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto | ||||||
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Public contact | |||||||
Name of contact person |
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Organization | Kyoto University Graduate School of Medicine | ||||||
Division name | Urology | ||||||
Zip code | |||||||
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TEL | |||||||
Homepage URL | |||||||
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 | |
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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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |