UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011513 |
|---|---|
| Receipt number | R000013469 |
| Scientific Title | Effects of herbal medicine Daikenchuto on the patients of refractory lower urinary tract symptoms or overactive bladder with constipation or hypersensitivity to cold |
| Date of disclosure of the study information | 2013/08/20 |
| Last modified on | 2013/08/19 01:34:10 |
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Basic information
Public title
Effects of herbal medicine Daikenchuto on the patients of refractory lower urinary tract symptoms or overactive bladder with constipation or hypersensitivity to cold
Acronym
Effects of Daikenchuto on the patients of lower urinary tract symptoms with constipation or hypersensitivity to cold
Scientific Title
Effects of herbal medicine Daikenchuto on the patients of refractory lower urinary tract symptoms or overactive bladder with constipation or hypersensitivity to cold
Scientific Title:Acronym
Effects of Daikenchuto on the patients of lower urinary tract symptoms with constipation or hypersensitivity to cold
Region
| Japan |
Condition
Condition
overactive bladder / lower urinary tract symptoms
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the role of Daikenchuto on lower urinary tract symptoms patients with constipation or hypersensitivity to cold
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
international prostate symptom score (IPSS), quality of life (QOL) score, and overactive bladder symptom score (OABSS)
Key secondary outcomes
voided volume, Qmax, Qave, and residual urine volume
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
Administration of Daikenchuto (15.0g/day, p.o.) for 1 month
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Refractory LUTS/OAB patients were defined as LUTS/OAB patients who had not been controlled well under conventional drugs including alpha-blocker, anticholinergic drug, and 5-alpha-reductase inhibitor.
Key exclusion criteria
Patients were excluded if they had confirmed prostate cancer, acute or chronic prostatitis within the previous 3 months, serum prostate-specific antigen levels over 4 ng/mL, a history of recurrent urinary tract infection or bladder stones, and previous transurethral resection of prostate or other surgical intervention related to bladder or prostate cancer.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Nishizawa |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
TEL
Homepage URL
minagawat@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of urology, Shinshu University, School of Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2013 | Year | 08 | Month | 19 | Day |
Last modified on
| 2013 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013469
| 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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