UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007068 |
|---|---|
| Receipt number | 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 14:46:32 |
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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
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
Sponsor or person
Institute
Department of General Internal Medicine, Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008327
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
