UMIN-CTR Clinical Trial

Basic information
Public title	The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy
Acronym	The efficacy and safety of rikkunshito on gastrointestinal symptoms after gastrectomy
Scientific Title	The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy
Scientific Title:Acronym	The efficacy and safety of rikkunshito on gastrointestinal symptoms after gastrectomy
Region	Japan

Condition
Condition	Gastric cancer patient who underwent gastrectomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of rikkunshito on gastrointestinal symptoms in gastric cancer patients who underwent gastrectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) QOL score (ES3/EGQ, GSRS, SF-12) 2) body weight 3) body mass index 4) nutritional factor (Alb, Pre-Alb, TP, T-Cho, WBC, Lym)
Key secondary outcomes	1)AST,ALT, GGTP,ALP,T-Bil, RBC, Hb, Hct, CRP, Na, K, creatinine, BUN 2)adverse events 3)side effects

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	Oral administration of rikkunshito (2.5g t.i.d) before meals for 162 days
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who underwent LAPPG or LADG 2) Reconstructive surgery: no object 3) Staging of gastric cancer is IA (UICC TNM classification) 4) Patients with anorexia, early satiation, or postprandial fullness 7 days after surgery 5) Age: &#8805; 20 6) Gender: no object 7) Outpatient or inpatient: no object 8) Agreement to sign an informed consent
Key exclusion criteria	1) Patients who have nutritional disorder before surgery 2) Patients who have another active malignancy 3) Patients with severe complications(ASA >=3 or PS>=2) 4) Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation 5) Patients with mental disorder considered inappropriate by the study doctor 6) Patients with adjuvant chemotherapy after surgery 7) Patients receiving KAMPO medicine 8) Patients who has history of hypersensitivity to Kampo medicine 9) Patients who are pregnant, considering pregnancy or lactation 10) Patients considered inappropriate by the study investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Hiki
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterological Surgery
Zip code
Address	3-8-31, Ariake, Koto, Tokyo
TEL	03-3520-0111
Email

Public contact
Name of contact person	1st name Middle name Last name Naoki Hiki
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterological Surgery
Zip code
Address	3-8-31, Ariake, Koto, Tokyo
TEL	03-3520-0111
Homepage URL
Email

Sponsor
Institute	The Cancer Institute Hospital of JFCR Gastroenterological Surgery
Institute
Department

Funding Source
Organization	TSUMURA & CO.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	がん研有明病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 07 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	2013 Year 04 Month 22 Day
Date of IRB	2013 Year 05 Month 02 Day
Anticipated trial start date	2013 Year 06 Month 07 Day
Last follow-up date	2014 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 06 Month 04 Day
Last modified on	2021 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012724