UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004311 |
|---|---|
| Receipt number | R000005168 |
| Scientific Title | Effect of Rikkunshito, a Herbal Medicine, on side effect in Patients After Gastrectomy |
| Date of disclosure of the study information | 2010/10/04 |
| Last modified on | 2010/10/02 10:40:01 |
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Basic information
Public title
Effect of Rikkunshito, a Herbal Medicine, on side effect in Patients After Gastrectomy
Acronym
Effect of Rikkunshito, a Herbal Medicine, on side effect in Patients After Gastrectomy
Scientific Title
Effect of Rikkunshito, a Herbal Medicine, on side effect in Patients After Gastrectomy
Scientific Title:Acronym
Effect of Rikkunshito, a Herbal Medicine, on side effect in Patients After Gastrectomy
Region
| Japan |
Condition
Condition
After Gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of rikkunshito on side effet in patient after gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of digestive sympton
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rikkunshito
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Written informed consent
2)Patients who is judged by investigator to be able to receive the protocol therapy
3)Age; 20<=, <=80
4)ECOG performance status 0-1
Key exclusion criteria
1)severe allergic reaction
2)Simultaneous or metachronous double cancers
3)Active infectious disease
4)systemic administration of corticosteroids
5)Pregnant or lactating women or women of childbearing potential
6)Severe comorbidity (interstitial peumonitis, lung fibrosis, paralytic ileus, mechanical ileus, uncontrollable diabetes, liver cirosis, chronic hepatitis, career with hepatitis B/C, renal failure, heart failure, uncontrollable hypertension, unstable angina etc)
7)AMI within 6 months
8)History of transplantation
9)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
Tokushima University
Division name
Department of surgery
Zip code
Address
kuramoto3-18-15, tokushima, tokushima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima University
Division name
Department of surgery
Zip code
Address
TEL
Homepage URL
morimoto@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Department of surgery, Tokushima university
Institute
Department
Personal name
Funding Source
Organization
Department of surgery, Tokushima university
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 10 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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 | 10 | Month | 02 | Day |
Last modified on
| 2010 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005168
