irritable bowel syndrome
Conditions
Interventions
The eligible patients receive oral Keishikashakuyakuto 2.5g trice per day before or between meals for 8 weeks
The eligible patients receive oral placebo 2.5g trice per day before or between mealsfor 8
Sponsors
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Fujita Health Univercity Kawasaki Medical School Aichi Medical University Hiratsuka City Hospital Yokosuka City Uwamachi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparison of the change in IBS-QOL overall score from pre-to posttreatment among two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAkiko Fuyuki
Yokohama City University school of medicine Department of gastroenterology and hepatology
Outcome results
None listed