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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026235
Receipt No. 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 2017/02/20

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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
Middle name
Last name Atsushi Nakajima
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 nakajima-tky@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
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
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
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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 15 Day
Date of IRB
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
2017 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.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


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