The efficacy of Traditional Japanese Medicine"keishikasyakuyakuto" for irritable bowel syndrome:A multi-center, double-blinded, placebo-controlled, randomized trial
- Conditions
- irritable bowel syndrome
- Registration Number
- JPRN-UMIN000026235
- Lead Sponsor
- Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 300
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The comparison of the change in IBS-QOL overall score from pre-to posttreatment among two groups
- Secondary Outcome Measures
Name Time Method 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