UMIN-CTR Clinical Trial

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
Email	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
Email	mkanou0911@yahoo.co.jp

Sponsor
Institute	Hiroshima City Asa Citizens Hospital, Department of Surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034421