irritable bowel syndrome colonic diseases, functional
Conditions
Interventions
A: Yokukansankachimpihange 7.5 g per day for 12 weeks
B: Potato starch 7.5 g per day for 12 weeks
Kampo
Sponsors
Kanazawa Motoyori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with IBS diagnosed with Rome IV criteria 2. Patients treated at the 1st step in clinical practice guideline of JSGE 2014 at least 4 weeks before randomization. 3. Condition with STAI-state score >= 41 4. Aged 16-75 years at the time of informed consent 5. Provision of written informed consent
Exclusion criteria
Exclusion criteria: 1. Major abdominal surgery (except appendectomy or hysterectomy) 2. History of inflammatory bowel disease, ischemic colitis, malignant tumor 3. Severe neurological complications (Parkinson's disease, Shy-Drager syndrome, schizophrenia, bipolar disorder) 4. Use of Kampo within 4 weeks prior to randomization 5. Allergy to Kampo 6. Lactose intolerance 7. Allergy to Starch 8. Severe complications (hepatic diseases, serious cardiovascular diseases, hematological diseases, metabolic diseases or malignant neoplasms) 9. Pregnancy, breastfeeding or planning on becoming pregnant throughout the course of the study 10. Unable to take MRI 11. Lack of suitability for participation in the study for any reason as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in outcome of STAI State Anxiety Inventory score at 12weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. STAI Trait Anxiety Inventory score 2. HADS score 3. IBS-QOL score 4. Daily number of stools 5. Stool consistency 6. Abdominal pain severity, abdominal fullness, anxiety score 7. Improvement rates of abdominal pain severity, abdominal fullness, Anxiety score 8. Insomnia Severity Index | — |
Contacts
Public ContactMotoyori Kanazawa
Tohoku University Hospital
Outcome results
None listed