UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009593 |
|---|---|
| Receipt number | R000011254 |
| Scientific Title | Clinical effects of Goshajinkigan for overactive bladder in female patients and correlation between severity of OAB symptoms and coldness. |
| Date of disclosure of the study information | 2012/12/20 |
| Last modified on | 2012/12/20 15:31:56 |
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Basic information
Public title
Clinical effects of Goshajinkigan for overactive bladder in female patients and correlation between severity of OAB symptoms and coldness.
Acronym
Clinical effects of Goshajinkigan for overactive bladder in female patients
Scientific Title
Clinical effects of Goshajinkigan for overactive bladder in female patients and correlation between severity of OAB symptoms and coldness.
Scientific Title:Acronym
Clinical effects of Goshajinkigan for overactive bladder in female patients
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the benefit of Kampo-Goshajinkigan in female patietns with overactive bladder and correlation between the severity of OAB symptoms and coldness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
OABSS
Key secondary outcomes
1)Symptom score of coldness
2)IPSS
3)Body temperature
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Goshajinnkigan 7.5g PO tid for 4 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)Written informed consent
2)OABSS Q3 2<=, OABSS total score 3<=
Key exclusion criteria
1)On-going Kampo-therapy
2)Neurogenic bladder
3)Previous XRT therapy for whole pevis
4)UTI
5)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyohiko Watanabe |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Urology
Zip code
Address
2-5-1, Shikata, Okayama 700-8558, Japan
TEL
086-235-7287
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyohiko Watanabe |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Urology
Zip code
Address
2-5-1, Shikata, Okayama 700-8558, Japan
TEL
086-235-7287
Homepage URL
Sponsor or person
Institute
Department of Urology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
岡山大学病院（岡山県），川崎医科大学附属病院（岡山県），倉敷成人病センター（岡山県），岡山労災病院（岡山県），しな子レディースクリニック（岡山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 27 | 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 | 12 | Month | 20 | Day |
Last modified on
| 2012 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011254
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
