UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001797 |
|---|---|
| Receipt number | 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 13:15:34 |
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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
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
Sponsor or person
Institute
TJ-100 IBS study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002167
