Unique ID issued by UMIN | UMIN000011349 |
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Receipt number | R000013301 |
Scientific Title | Assessment for efficacy of combination therapy with Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection. |
Date of disclosure of the study information | 2013/08/05 |
Last modified on | 2015/02/19 11:53:20 |
Assessment for efficacy of combination therapy with Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection.
Efficacy of "Shin-bu-to" combination therapy for Clostridium difficile infection.
Assessment for efficacy of combination therapy with Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection.
Efficacy of "Shin-bu-to" combination therapy for Clostridium difficile infection.
Japan |
Clostridium difficile infection.
Infectious disease |
Others
NO
To assess the efficacy of Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection, "Shin-bu-to" is prescribed combined with basic therapy for patients with Clostridium difficile infection.
Safety,Efficacy
Exploratory
Pragmatic
Duration of symptoms (mainly diarrhea) between patients with basic therapy and combination therapy.
Assessment of prolonged symptoms in day 3 and 5.
Assessment of adverse effects.
Assessment of dehydration.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Basic therapy; Oral Vancomycin 125mg 4 times / day for 10 days.
Combination therapy; Oral Vancomycin 125mg 4 times / day for 10 days plus Shin-bu-to (commercially available dry extract) until symptom improve.
20 | years-old | <= |
Not applicable |
Male and Female
Inpatient.
Clinically diagnosed with Clostridium difficile infection based on watery diarrhea and positive CD toxin or CD-GDH antigen.
Consent to participate this study.
Over or equal to 20 year old.
Diagnosed as "kyo (weakened)" based on Japanese herbal medicine.
Shock status.
Conscious disturbance.
Needs intensive care.
Unable to take drugs orally due to interstitial dysfunction.
Recurrent case of Clostridium difficile infection.
60
1st name | |
Middle name | |
Last name | Takeshi Kaneko |
Yokohama City University Medical Center
Infection Control Department
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
1st name | |
Middle name | |
Last name | Hideaki Kato |
Yokohama City University Medical Center
Infection Control Department
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
Yokohama City University Medical Center
None
Self funding
JAPAN
NO
2013 | Year | 08 | Month | 05 | Day |
Unpublished
Terminated
2013 | Year | 07 | Month | 04 | Day |
2013 | Year | 08 | Month | 05 | Day |
2013 | Year | 08 | Month | 02 | Day |
2015 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013301
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