Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000019249
- Lead Sponsor
- Division of Gastroenterology and Hepatology, School of Medicine, Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1 Patients' CDAI was more than 450 or less than 150 at the entry 2 The patients were not treated with infliximab within 7 weeks. The patients were not treated with adalimumab within 10 days. 3 The presence of abdominal abscess 4 Patients had colitis-associated dysplasia. 5 Patients had symptomatic intestinal stenosis 6 Patients had pouch or stoma. 7 Patients have the history of side effect or allergy of Chinese herbal medicine. 8 Patients have serious infections. 9 Patients have serious heart disease 10 Serum creatinine is more than 2.0mg/dL 11 Total bilirubin is more than 2.0mg/dL or AST/ALT is more than 50IU/L 12 Patients have history of malignant diseases 13 Patients have obvious psychological disorders 14 Patients are pregnant or patients wish to conceive. 15 Changing the dose/addition/reduction of medication for CD within 12 weeks before the commencement of the study was not allowed. 16 Investigators regard the patients as the inappropriate person to enroll this clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of clinical remission (CDAI is less than 150 at 8 weeks after the entry)
- Secondary Outcome Measures
Name Time Method