Unique ID issued by UMIN | UMIN000000751 |
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Receipt number | 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 09:05:58 |
Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder: A Randomized, Double-blind, Placebo-Controlled Trial.
Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder.
Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder: A Randomized, Double-blind, Placebo-Controlled Trial.
Efficacy of hangekobokuto, a representative Kampo (Japanese herbal medicine) formula for Ki congestion, in overactive bladder.
Japan |
Overactive bladder
Urology |
Others
NO
To evaluate the efficacy of hangekobokuto in overactive bladder
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
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)
urine flow, residual urine volume, PSA(prostate specific antigen), pupillary light reflex, Kampo findings, adverse events
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Spray-dried tablet of hangekobokuto, 12 tablets per day
Placebo tablet, 12 tablets per day
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
98
1st name | |
Middle name | |
Last name | Hiroshi Odaguchi |
Oriental Medicine Research Center, Kitasato University
Clinical Trial Division
5-9-1, Shirokane, Minatoku, Tokyo
03-3444-6161
1st name | |
Middle name | |
Last name | Hiroshi Odaguchi |
Oriental Medicine Research Center, Kitasato University
Clinical Trial Division
5-9-1, Shirokane, Minatoku, Tokyo
03-3444-6161
odaguchi@insti.kitasato-u.ac.jp
Oriental Medicine Research Center, Kitasato University
Oriental Medicine Research Center, Kitasato University
Self funding
Kitasato Institute Hospital
NO
2007 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2007 | Year | 06 | Month | 13 | Day |
2007 | Year | 07 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2011 | Year | 01 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2007 | Year | 06 | Month | 27 | Day |
2010 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000891
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