UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003731 |
|---|---|
| Receipt number | R000004519 |
| Scientific Title | The exploratory analaysis for the efficacy and safety of Rikkunshito for appetite loss during the treatment with PEG-IFN and ribavirin |
| Date of disclosure of the study information | 2010/06/10 |
| Last modified on | 2013/06/21 17:57:11 |
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Basic information
Public title
The exploratory analaysis for the efficacy and safety of Rikkunshito for appetite loss during the treatment with PEG-IFN and ribavirin
Acronym
The analaysis for the efficacy and safety of Rikkunshito for appetite loss during the treatment with PEG-IFN and ribavirin
Scientific Title
The exploratory analaysis for the efficacy and safety of Rikkunshito for appetite loss during the treatment with PEG-IFN and ribavirin
Scientific Title:Acronym
The analaysis for the efficacy and safety of Rikkunshito for appetite loss during the treatment with PEG-IFN and ribavirin
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The analysis for the efficacy and safety of rikkunshito for appetite loss during the treatment with PEG-IFN and ribavirin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Appetite loss
Key secondary outcomes
QOL of gastrointestinal symptom
Change of ghrelin and leptin
body weight
Depression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rikkunshito 7.5g per day 2 weeks
Interventions/Control_2
Domperidone 30mg per day 2 weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) The patients with chronic hepatitis C
(2) During the treatment with PEG-IFN + Ribavirin
(3)Appetite loss
Key exclusion criteria
(1)post gastrectomy
(2)Use of other Kampo medicine
(3)Gastrointestinal bleeding, ilues, perforation of gut
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
gastrointestinal medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku,Chiba City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University Hospital
Division name
gastrointestinal medicine
Zip code
Address
TEL
043-226-2083
Homepage URL
Sponsor or person
Institute
Department of Gastrointestinal Medicine, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastrointestinal Medicine, Chiba University Hospital
Organization
Division
Category of Funding Organization
Other
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
千葉大学病院（千葉県）、キッコーマン総合病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | 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
| 2010 | Year | 06 | Month | 10 | Day |
Last modified on
| 2013 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004519
| 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 |
