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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007068
Receipt No. R000008327
Scientific Title The Effectiveness of Shimbuto and Ninjinto Japanese Kampo Herbal Medicines in combination with Pegylated interferon alpha plus ribavirin for patients with chronic hepatitis C A pilot study
Date of disclosure of the study information 2012/01/15
Last modified on 2012/01/15

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Basic information
Public title The Effectiveness of Shimbuto and Ninjinto Japanese Kampo Herbal Medicines in combination with Pegylated interferon alpha plus ribavirin for patients with chronic hepatitis C A pilot study
Acronym Shimbuto and Ninjinto, Pegylated alpha Interferon plus ribavirin
Scientific Title The Effectiveness of Shimbuto and Ninjinto Japanese Kampo Herbal Medicines in combination with Pegylated interferon alpha plus ribavirin for patients with chronic hepatitis C A pilot study
Scientific Title:Acronym Shimbuto and Ninjinto, Pegylated alpha Interferon plus ribavirin
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study we test hypothesis that
mixture of Shimbuto and Ninginto extract can give safety and efficacy in pegylated alpha plus ribavirin treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes VIrological response rate by Abbott RealTime PCR
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are randomly devided into two groups combination treatment of pegylated interferon alpha(1.5 microg/kg/week)and ribavirin(600-1000mg/day) with extract of Shimbuto and Ninjinto(15g/day) or not from 2008 to 2011
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All were positive for antibody to HCV and HCV RNA for over 6 months
Key exclusion criteria Exclusion criteria are follows
1)concomitant liver disease (hepatitis B surface antigen positive or Human immunodeficiency virus positive)
2)clinical or biochemical evidence of hepatic decompensation, advanced cirrhosis
3)excessive active alcohol consumption>60g/day or drug abuse
4)evidence of hepatocellula carcinoma
5) antiviral or immunosuppressive treatment within 12 months prior to enrollment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hayashi
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, HIgashi-ku, Fukuoka, Japan
TEL 092-642-5909
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mosaburo Kainuma
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, HIgashi-ku, Fukuoka, Japan
TEL 092-642-5909
Homepage URL
Email

Sponsor
Institute Department of General Internal Medicine, Kyushu University Hospital
Institute
Department

Funding Source
Organization Department of General Internal Medicine, Kyushu University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2012 Year 01 Month 15 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
2008 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 15 Day
Last modified on
2012 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008327

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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