Irritable bowel syndrome
Conditions
Interventions
Oral administration of Daikenchuto 15g/day b.i.d or t.i.d. before meals or between meals.
Oral administration of polycarbophil 1.5-3.0g/day t.i.d. after meals.
Sponsors
TJ-100 IBS study group
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS-QOL-J | — |
Countries
Japan
Outcome results
None listed