Exploratory study evaluating efficacy, safety and mechanism of Daikenchuto on abdominal pain or bloating accompanied by Crohn disease.
Not Applicable
Recruiting
- Conditions
- Subjects with quiescent Crohn disease having abdominal pain or bloating
- Registration Number
- JPRN-UMIN000012635
- Lead Sponsor
- Kurume university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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