UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029543