UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022282
Receipt number R000025623
Scientific Title The efficacy of Keishikashakuyakuto for irritable bowel syndrome
Date of disclosure of the study information 2016/05/11
Last modified on 2016/11/30 00:01:13

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Basic information

Public title

The efficacy of Keishikashakuyakuto for irritable bowel syndrome

Acronym

The efficacy of Keishikashakuyakuto for IBS

Scientific Title

The efficacy of Keishikashakuyakuto for irritable bowel syndrome

Scientific Title:Acronym

The efficacy of Keishikashakuyakuto for IBS

Region

Japan


Condition

Condition

Irritable bowel syndrome

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the efficacy of Keishikashakuyakuto for irritable bowel syndorome.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The score of IBS-QOL at study entry and at the end of 2-months drug intervention

Key secondary outcomes

1,The rate of improvement of IBS-QOL score at the end of 2-months drug intervention
2,The rate of improvement of IBS-QOL score at the end of 2-months drug intervention according to type of IBS
3,The rate of improvement of IBS-SI score at the end of 2-months drug intervention
4,The score of IBS-SI at study entry and at the end of 2-months drug intervention
5,The rate of improvement of IBS-QOL score at the end of 1-months drug intervention


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Keishikashakuyakuto 7.5g/day, daily three times, for two months

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, The patients who meet the IBS criteria by ROMEIII
2, Patients who had past history of IBS and are going on medical treatment for more than 4 weeks before entry
3, Patients who can exhibit their consent in a document

Key exclusion criteria

1,Patients who had history of gastrointestinal tract resection
2,Patients who have severe complications
3,Patients who have history of Kampo allergies
4,Patients who have history of lactose intolerance
5,Patients who had taken new drug therapy within 4 weeks before entry
6,Patients who had any change in types, dosage, or adiministration of their prescribed drugs within 4 weeks before entry
7,Patients who are or are going to be participating in other clinical studies
8,Patients who are pregnant or possibly pregnant
9,Patients who are judged as inadequately for study entry

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fuyuki Akiko

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

fuyuki-sin@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fuyuki Akiko

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Homepage URL


Email

fuyuki-sin@umin.ac.jp


Sponsor or person

Institute

Yokohama City University School of Medicine Department of Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University School of Medicine Department of Gastroenterology and Hepatology

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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 11 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

2016 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 11 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

2016 Year 05 Month 11 Day

Last modified on

2016 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025623


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name