UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030827 |
|---|---|
| Receipt number | R000034421 |
| Scientific Title | Randomized controlled trial to examine an effect of the Rikkunshito for stasis of post-gastrectomy |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2021/01/18 15:22:12 |
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Basic information
Public title
Randomized controlled trial to examine an effect of the Rikkunshito for stasis of post-gastrectomy
Acronym
Rikkunshito trial for stasis of post-gastrectomy
Scientific Title
Randomized controlled trial to examine an effect of the Rikkunshito for stasis of post-gastrectomy
Scientific Title:Acronym
Rikkunshito trial for stasis of post-gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the effect of the Rikkunshito for stasis of postgastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement in the quality of life (QOL)
by questionnaire after therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medication of rikkunshi-to,
4-weeeks, 7.5g/day
Interventions/Control_2
no-treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients who had undergone distal or pylorus preserved gastrectomy
2 Patients with gastric cancer from clinical Stage IA to IIIC
3 ECOG Performance Status of 0 or 1
4 The cases that an agreement was obtained after enough explanation
Key exclusion criteria
1 Patients who are receiving chemotherapy
2 Patients who had received neoadjuvant chemotherapy
3)Multiple primary cancers
4 Patients with complicated resection excluding cholecystectomy
5 Patients who had done intestinal resection
6 Severe complication of circulatory organ respiratory apparatus liver kidney AST or ALT are exceed 2.5 times of the institution reference value Cr 2.0mg/dL over HbA1c 7.0% over
7 Received medications which affect the gut hormones,Daikenchu-to Chinpi Liraglutide capromorelin etc
8 Other patients inappropriate for this study in the opinion of the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Hihara |
Organization
Hiroshima City Asa Citizens Hospital
Division name
Department of Surgery
Zip code
731-0293
Address
Kabe-Minami 2-1-1, Asakita-ku, Hiroshima
TEL
082-815-5211
hihara@mac.com
Public contact
Name of contact person
| 1st name | Kano |
| Middle name | |
| Last name | Mikihiro |
Organization
Hiroshima City Asa Citizens Hospital
Division name
Department of Surgery
Zip code
731-0293
Address
Kabe-Minami 2-1-1 Asakita-ku Hiroshima
TEL
082-815-5211
Homepage URL
mkanou0911@yahoo.co.jp
Sponsor or person
Institute
Hiroshima City Asa Citizens Hospital, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hiroshima City Asa Citizens Hospital
Address
Kabe-Minami 2-1-1 Asakita-ku Hiroshima
Tel
0828155211
mkanou0911@yahoo.co.jp
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
| 2018 | 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
| 2017 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034421
