UMIN-CTR Clinical Trial

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

Gastric cancer patient who underwent
laparoscopy assisted gastrectomy or
open gastrectomy

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖マリアンナ医科大学病院（神奈川県）
St.Marianna University School of Medicine Hospital

Date of disclosure of the study information

2012

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

07

Month

30

Day

Last modified on

2016

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009842