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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000751
Receipt No. R000000891
Scientific Title Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder: A Randomized, Double-blind, Placebo-Controlled Trial.
Date of disclosure of the study information 2007/07/01
Last modified on 2010/12/27

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Basic information
Public title Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder: A Randomized, Double-blind, Placebo-Controlled Trial.
Acronym Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder.
Scientific Title Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder: A Randomized, Double-blind, Placebo-Controlled Trial.
Scientific Title:Acronym Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder.
Region
Japan

Condition
Condition Overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of hangekobokuto in overactive bladder
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes OABSS(Overactive Bladder Symptom Score), KHQ(King's Health Questionnaire), SF-36 (MOS Short-Form 36-Item Health Survey), IPSS(International Prostate Symptom Score)(mele only)
Key secondary outcomes urine flow, residual urine volume, PSA(prostate specific antigen), pupillary light reflex, Kampo findings, adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Spray-dried tablet of hangekobokuto, 12 tablets per day
Interventions/Control_2 Placebo tablet, 12 tablets per 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria OAB patients: patients whose score in the 3rd question is equal to or more than two points and that in total is equal to or more than three points in OABSS.
Key exclusion criteria 1.Patients currently taking any Kampo medicine
2.Patients having taken any Kampo medicine in the past 4 weeks
3.Patients with clinically significant liver or renal dysfunction
4.Patients with some diseases which might influence their general condition, for example, cancer or heart failure
5.Patients considered inappropriate for this trial by the physicians-in-charge
Target sample size 98

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Odaguchi
Organization Oriental Medicine Research Center, Kitasato University
Division name Clinical Trial Division
Zip code
Address 5-9-1, Shirokane, Minatoku, Tokyo
TEL 03-3444-6161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Odaguchi
Organization Oriental Medicine Research Center, Kitasato University
Division name Clinical Trial Division
Zip code
Address 5-9-1, Shirokane, Minatoku, Tokyo
TEL 03-3444-6161
Homepage URL
Email odaguchi@insti.kitasato-u.ac.jp

Sponsor
Institute Oriental Medicine Research Center, Kitasato University
Institute
Department

Funding Source
Organization Oriental Medicine Research Center, Kitasato University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitasato Institute Hospital
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
2007 Year 07 Month 01 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
2007 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 06 Month 27 Day
Last modified on
2010 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000891

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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