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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011349
Receipt No. 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

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Basic information
Public title Assessment for efficacy of combination therapy with Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection.
Acronym Efficacy of "Shin-bu-to" combination therapy for Clostridium difficile infection.
Scientific Title Assessment for efficacy of combination therapy with Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection.
Scientific Title:Acronym Efficacy of "Shin-bu-to" combination therapy for Clostridium difficile infection.
Region
Japan

Condition
Condition Clostridium difficile infection.
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Duration of symptoms (mainly diarrhea) between patients with basic therapy and combination therapy.
Key secondary outcomes Assessment of prolonged symptoms in day 3 and 5.
Assessment of adverse effects.
Assessment of dehydration.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Basic therapy; Oral Vancomycin 125mg 4 times / day for 10 days.
Interventions/Control_2 Combination therapy; Oral Vancomycin 125mg 4 times / day for 10 days plus Shin-bu-to (commercially available dry extract) until symptom improve.
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 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.
Key exclusion criteria Shock status.
Conscious disturbance.
Needs intensive care.
Unable to take drugs orally due to interstitial dysfunction.
Recurrent case of Clostridium difficile infection.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kaneko
Organization Yokohama City University Medical Center
Division name Infection Control Department
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Kato
Organization Yokohama City University Medical Center
Division name Infection Control Department
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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 05 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 Terminated
Date of protocol fixation
2013 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 05 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 02 Day
Last modified on
2015 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013301

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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