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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001797
Receipt No. R000002167
Scientific Title Randomized controlled trial to determine the efficacy and safety of daikenchuto for abdominal pain and bloating sensation of IBS
Date of disclosure of the study information 2009/03/25
Last modified on 2010/04/27

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Basic information
Public title Randomized controlled trial to determine the efficacy and safety of daikenchuto for abdominal pain and bloating sensation of IBS
Acronym Randomized controlled trial of the effect of daikenchuto on IBS symptom
Scientific Title Randomized controlled trial to determine the efficacy and safety of daikenchuto for abdominal pain and bloating sensation of IBS
Scientific Title:Acronym Randomized controlled trial of the effect of daikenchuto on IBS symptom
Region
Japan

Condition
Condition Irritable bowel syndrome
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of daikenchuto and calcium polycarbophil on IBS symptom, abdominal pain and bloating sensation are determined by VAS and IBS-QOL at 4 week. Intestinal flora is also estimated to investigate the mechanism of the effect.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IBS-QOL-J
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of Daikenchuto 15g/day b.i.d or t.i.d. before meals or between meals.
Interventions/Control_2 Oral administration of polycarbophil 1.5-3.0g/day t.i.d. after meals.
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Selection criteria at the time obtain informed consent.
1) Patients who are diagnosed as IBS by Rome III criteria.
2) Patients who have abdominal pain and bloating sensation.
3) Patients who are 20~65 years of age.
4) Gender: no specification
5) Consultation method: no specification
6) Patients who can provide the written informed consent.

2. Selection criteria at the time admission to the study.
1) Patients who discontinue use of any IBS medication at least 7 days prior to admission to the study.
2) Patients who wrote daily report of IBS symptom 7 days prior to admission to the study.
3) Patients who collected fecal sample at least 7 days prior to admission to the study.
Key exclusion criteria 1) Patients who have bowel move disturbance by organic lesion such as IBD(UC and crohn disease etc.) and cancer.
2) Patients suspected of obstruction in stomach and intestines, and with a history of total gastric resection or bowel resection but not apendicitis
3) Patients with hypercalcemia, calculus in the kidney and dysfunction of kidneys.
4) Patients who are taking cardiac glycoside and tetracyclines antibiotics.
5) Patients who took antibiotics at least 2 month prior to observation period
6) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder)
7) Patients with a history of drug allergy
8) Patients who are nursing, pregnant or considering conception
9) Patients who are taking Kampo medicine.
10) Others, including patients who are unfit for the study as determined by the research director or others
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoichi Takayanagi
Organization Kyushu University Hospital
Division name Department of Hepatology and Pancreatology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyushu University Hospital
Division name Department of Hepatology and Pancreatology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
Homepage URL
Email

Sponsor
Institute TJ-100 IBS study group
Institute
Department

Funding Source
Organization Tsumura & Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
2009 Year 03 Month 25 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 Completed
Date of protocol fixation
2008 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 25 Day
Last modified on
2010 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002167

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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