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


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 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


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

Value
https://center6.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