UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011513
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email minagawat@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013469

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.