UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009829
Receipt number R000011516
Scientific Title The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI
Date of disclosure of the study information 2013/01/21
Last modified on 2013/01/21 22:31:41

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Basic information

Public title

The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI

Acronym

The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI

Scientific Title

The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI

Scientific Title:Acronym

The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI

Region

Japan


Condition

Condition

HCC

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To reveal the efficay of Rikkunshito for nausea and appetite loss in the treatment of HCC

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement of nausea and appetite loss

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rikkunshito

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

HCC who are treated by TAI

Key exclusion criteria

It depends on Physician's dicision

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Yokosuka

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba City

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code


Address


TEL

043-226-2083

Homepage URL


Email



Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Tsumura Co.

Organization

Division

Category of Funding Organization

Profit organization

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

2013 Year 01 Month 21 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

2007 Year 03 Month 06 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 21 Day

Last modified on

2013 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011516


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name