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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008564
Receipt No. R000009842
Scientific Title The study for the efficacy of rikkunshito on anorexia in the patients who underwent laparoscopy assisted gastrectomy and open gastrectomy
Date of disclosure of the study information 2012/07/31
Last modified on 2016/03/03

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Basic information
Public title The study for the efficacy of
rikkunshito on anorexia in the
patients who underwent laparoscopy
assisted gastrectomy and open
gastrectomy
Acronym The efficacy of rikkunshito on anorexia
after gastrectomy
Scientific Title The study for the efficacy of
rikkunshito on anorexia in the
patients who underwent laparoscopy
assisted gastrectomy and open
gastrectomy
Scientific Title:Acronym The efficacy of rikkunshito on anorexia
after gastrectomy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy of rikkunshito on
anorexia after laparoscopy assisted gastrectomy or open gastrectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Variance analysis in clinical pathway
Key secondary outcomes 1) Body weight
2) Gastrointestinal symptom(anorexia)
3) Inflammation
4) Fever
5) Postoperative first flatus
6) Anemia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of rikkunshito
(2.5g t.i.d) before or between meals for 12 months
Interventions/Control_2 Standard 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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Clinical Stage: IA-IIIA
2) Laparoscopy assisted gastrectomy
or Open gastrectomy
3) ECOG Performance Score 0- 1
4) Aged 20 to 85 years old
5) Signed informed consent
Key exclusion criteria 1) Patients who underwent total
gastrectomy
2) Patients with history of
radiotherapy to the abdomen
3) Patients scheculed to be under
postoperative artificial respiration
after surgery
4) Patients with inflammatory bowel
disease (ulcerative colitis, Crohn
disease) (including anamnestic case)
5) Patients with multiple cancer
6) Patients with synchronous colon
resection
7) Patients whose main organ function
is not working
8) Patients with history of laparotomy
and peritonitis (excludeing surgery
for appendicitis)
9) Patients who had administration of
other Kampo medicine 4 weeks prior
to the administration of test drug
10) Patients who are pregnant,
considering pregnancy or lactating
11) Patients considered inappropriate
by the study investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeharu Enomoto
Organization St.Marianna University School of
Medicine Hospital
Division name Department of Gastroenterological And General Surgery
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL 044-977-8111
Email takeharu@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeharu Enomoto
Organization St.Marianna University School of Medicine Hospital
Division name Department of Gastroenterological and General Surgery
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL 044-977-8111
Homepage URL
Email takeharu@marianna-u.ac.jp

Sponsor
Institute Department of Gastroenterological
and General Surgery
St.Marianna University School of
Medicine Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterological
and General Surgery
St.Marianna University School of
Medicine Hospital
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
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 聖マリアンナ医科大学病院(神奈川県)
St.Marianna University School of Medicine Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 31 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 Main results already published
Date of protocol fixation
2012 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2017 Year 03 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
2012 Year 07 Month 30 Day
Last modified on
2016 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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