UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025258
Receipt number R000028822
Scientific Title the effectiveness of Tsumura Rokkunsho for the patient with abdominal symptom caused to bile juice post distal gastrectomy
Date of disclosure of the study information 2016/12/13
Last modified on 2018/06/15 13:32:53

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Basic information

Public title

the effectiveness of Tsumura Rokkunsho for the patient with abdominal symptom caused to bile juice post distal gastrectomy

Acronym

the effectiveness of Tsumura Rokkunsho for the patient with abdominal symptom caused to bile juice post distal gastrectomy

Scientific Title

the effectiveness of Tsumura Rokkunsho for the patient with abdominal symptom caused to bile juice post distal gastrectomy

Scientific Title:Acronym

the effectiveness of Tsumura Rokkunsho for the patient with abdominal symptom caused to bile juice post distal gastrectomy

Region

Japan


Condition

Condition

post distal gastrectomy

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

the effectiveness of Tsumura Rikkunnsitou for the patient with abdominal symptom caused bile juice post distal gastrectomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the change of GerdQ score after 2weeks with Rikkunshitou

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rikkunnshito 1p trid 2weeks

Interventions/Control_2

camostat 100mg trid 2weeks

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

post distal gastrectomy
patients with heart burn,abdominal fullness or abdominal discomfort
take a H2 blocker or a proton pump inhibitor

Key exclusion criteria

serious heart disease, liver dysfunction or or renal dysfunction
patients take chemotherapy
patients with reccurence of cancer

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Mizuta

Organization

Kochi university

Division name

department of gastroenterology and hepatology

Zip code


Address

Nankoku city, Kochi

TEL

088-880-2338

Email

mizutahi@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Mizuta

Organization

Kochi university

Division name

department of gastroenterology and hepatology

Zip code


Address

Nankoku city, Kochi

TEL

088-880-2338

Homepage URL


Email

mizutahi@kochi-u.ac.jp


Sponsor or person

Institute

Kochi university, department of gastroenterology and hepatology

Institute

Department

Personal name



Funding Source

Organization

Kochi university, department of gastroenterology and hepatology

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 13 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

Terminated

Date of protocol fixation

2016 Year 11 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 11 Month 15 Day

Last follow-up date

2016 Year 12 Month 18 Day

Date of closure to data entry

2016 Year 12 Month 18 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 13 Day

Last modified on

2018 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name