UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026235
Receipt number R000029543
Scientific Title The efficacy of Traditional Japanese Medicine"keishikasyakuyakuto" for irritable bowel syndrome:A multi-center, double-blinded, placebo-controlled, randomized trial
Date of disclosure of the study information 2017/02/20
Last modified on 2021/02/24 13:23:09

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Basic information

Public title

The efficacy of Traditional Japanese Medicine"keishikasyakuyakuto" for irritable bowel syndrome:A multi-center, double-blinded, placebo-controlled, randomized trial

Acronym

The efficacy of "keishikasyakuyakuto"for
IBS:A multi-center,double-blinded,placebo-controlled,randomized trial

Scientific Title

The efficacy of Traditional Japanese Medicine"keishikasyakuyakuto" for irritable bowel syndrome:A multi-center, double-blinded, placebo-controlled, randomized trial

Scientific Title:Acronym

The efficacy of "keishikasyakuyakuto"for
IBS:A multi-center,double-blinded,placebo-controlled,randomized trial

Region

Japan


Condition

Condition

irritable bowel syndrome

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of Keishikashakuyakuto for QOL of IBS patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

The comparison of the change in IBS-QOL overall score from pre-to posttreatment among two groups

Key secondary outcomes

1,The comparison of the change in IBS-QOL overall score from pre-to after 4 weeks of treatment among two groups
2,The comparison of the changes in IBS-QOL score of 8 subscales from pre-to posttreatment among two groups
3,The comparison of the change in IBS-QOL overall score from pre-to posttreatment by 4 subtypes of IBS among two groups
4,The comparison of the change in IBS-SI score from pre-to posttreatment among two groups


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The eligible patients receive oral Keishikashakuyakuto 2.5g trice per day before or between meals for 8 weeks

Interventions/Control_2

The eligible patients receive oral placebo 2.5g trice per day before or between mealsfor 8 weeks

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1, Patients who are diagnosed IBS by ROME criteria
2, Patients who are excluded mechanical disorders by colonoscopy within five years
3, Patients who had past history of IBS and are going on medical treatment for more than 4 weeks before entry
4, Patients with IBS-QOL overall score under 70 and IBS-SI score over 175
5, 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 or current evidence of celiac disease or inflammatory bowel disease
4, Patients who under treatment with steroid or biological products
5, Patients who have severe psychiatric disease
6, Patients who have current evidence of abuse of drugs or alcohol
7, Patients who have history of Kampo allergies
8, Patients who had taken new drug therapy within 4 weeks before entry
10, Patients who had any change in types, dosage,or adiministration of their prescribed drugs within 4 weeks before entry
11, Patients who or are going to take new medicines
12, Patients who have been enrolled in previous clinical trials of Keishikashakuyakuto or have taken Keishikashakuyakuto before entry this trial
13, Patients who or are going to be participating in other clinical studies
14, Patients who are pregnant or possibly pregnant
15, Patients who are lactating
16, Patients who are judged as inadequately for study entry

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Nakajima

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code

236-0004

Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

nakajima-tky@umin.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Fuyuki

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code

236-0004

Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

0457872640

Homepage URL


Email

fuyukia@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University School of Medicine Department of Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Japan agency for medical research and development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Fujita Health Univercity
Kawasaki Medical School
Aichi Medical University
Hiratsuka City Hospital
Yokosuka City Uwamachi Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committe of Yokohama City University

Address

3-9 Fukuura Kanazawa-ku Yokohama City

Tel

045-787-2800

Email

rinri@yokohama-cu.ac.jp


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

2017 Year 02 Month 20 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

No longer recruiting

Date of protocol fixation

2016 Year 12 Month 15 Day

Date of IRB

2016 Year 12 Month 16 Day

Anticipated trial start date

2017 Year 02 Month 20 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry

2021 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 01 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 20 Day

Last modified on

2021 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029543


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name