UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011349
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

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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 or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



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

Value
https://center6.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