UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006966 |
|---|---|
| Receipt number | R000008222 |
| Scientific Title | Prophylactic effect of rikkunshito on bodyweight loss accompanied with anorexia after esophagectomy |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2019/07/04 09:30:18 |
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Basic information
Public title
Prophylactic effect of rikkunshito on bodyweight loss accompanied with anorexia after esophagectomy
Acronym
Effect of rikkunshito on anorexia after esophagectomy
Scientific Title
Prophylactic effect of rikkunshito on bodyweight loss accompanied with anorexia after esophagectomy
Scientific Title:Acronym
Effect of rikkunshito on anorexia after esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prophylactic effect of rikkunshito on bodyweight loss and malnutrition accompanied with anorexia after esophagectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of bodyweight
Key secondary outcomes
BMI, QOL
serum albumin, prealbumin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rikkunshi-to
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)patients with esophagealcancer who undergo esophagectomy with gastric conduit
2)an age of 20 years or older, 80 years or younger
3)PS(ECOG):0-2
4) written informed consent
Key exclusion criteria
1)serious comcomitant diseases
2)multiple primary cancer
3)impossible oral intake
4)adiminstration of Kampo within two weeks
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Nakamura |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
Kimiidera, Wakayama, Japan
TEL
073-441-0613
twins@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Nakamura |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
Kimiidera, Wakayama, Japan
TEL
073-441-0613
Homepage URL
twins@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Tsumura
Organization
Division
Category of Funding Organization
Profit 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
| 2011 | Year | 12 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008222
