Subjects with quiescent Crohn disease having abdominal pain or bloating
Conditions
Interventions
Administered group: Oral administration of Daikenchuto 15g/day for 24 weeks in addition to ordinary treatment for Crohn disease
Non-administered group: Ordinary treatment for Crohn disease
Sponsors
Kurume university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria at the time of obtaining patient agreement 1 Patients diagnosed with Crohn disease 2 Patients with abdominal pain or bloating 3 Age: 16 to 70 years old at the time of giving informed consent 4 Gender: Not specified 5 Inpatient/outpatient: Not specified 6 Patients who can give written informed consent (When patients are under the age of 20, written informed consent must be obtained by their legal guardians as well as by themselves) Selection criteria at the time of enrollment 1 Patients who had changed dosage and administration of other medication for Crhon disease just before 4 weeks of obtained the informed consent 2 Patients who had kept their patient diaries for seven days before enrollment 3 Patients with CDAI less than 150
Exclusion criteria
Exclusion criteria: 1 Patients with short bowel syndrome 2 Patients who require surgical treatment 3 Patients with malignancy 4 Patients who can take medicines orally 5 Patients under treatment for psychiatric disorder (including depression) 6 Patients with stoma 7 Patients who took Kampo medicines within 4weeks before enrollment 8 Patients taking drugs under development 9 Patients with serious complications (liver, kidney, heart, circulatory, or metabolic disorder) 10 Patients who are lactating, pregnant or considering conception 11 Others, including patients who are unfit for the study as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Abdominal pain (The questionnaire item in CDAI: Abdominal pain in the past week) 2 Abdominal bloating (Question 17 and 20 in Japanese version of IBDQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 CDAI 2 Japanese version of IBDQ 3 Serum concentrations and blood mRNA levels of following substances Adrenomedullin, CGRP, Receptors for adrenomedullin or CGRP and Cytokines 4 Protein and mRNA levels of following substances in peripheral mononuclear cells Adrenomedullin, CGRP, Cytokines and their receptors 5 Discontinuance rate of study | — |
Countries
Japan
Contacts
Public ContactHiroshi Yamasaki
Kurume university Division of gastroenterology, Department of medicine
Outcome results
None listed