UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of Keishikashakuyakuto for irritable bowel syndrome
Title of the study (Brief title)	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	Fuyuki Akiko
Organization	Yokohama City University school of medicine
Division name	Department of gastroenterology and hepatology
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Email	fuyuki-sin@umin.ac.jp

Public contact
Name of contact person	Fuyuki Akiko
Organization	Yokohama City University school of medicine
Division name	Department of gastroenterology and hepatology
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Homepage URL
Email	fuyuki-sin@umin.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025623