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
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
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
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
