Crohn'
Conditions
Interventions
Rosuvastatin (Crestor) 0mg/day: Control group
Rosuvastatin (Crestor) 5mg/day: Low-dose group
Rosuvastatin (Crestor) 20mg/day: High-dose group
Sponsors
Department of lower gastroenterology, Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute Crohn's disease patient with more than 200 points and less than 450 points in the Crohn's activity index (CDAI), and higher than 0.5mg/dl of serum CRP level at enrollment. Candidate has to agree to be enrolled for the study under sufficient written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients treating hyperlipidemia with or without statins. (2) Patients of hypothyroidism (TSH elevates 1.5 times or higher than the normal limits) (3) Patient with high creatine kinase (3.0 times or higher than the normal limits) (4) Serum creatinine higher than 2.0 mg/dl (5) Liver dysfunction (ALT elevates 2.0 times or higher than the normal limits) (6) Past episode of malignancy and/or alcoholic or drug dependence (7) Women under or expecting pregnancy (8) Patients of acute inflammatic disease (9) Patients with having past episode of severe allergy (10) Patients have been enrolled for other clinical trial within past 3 months and/or enrolling other trial currently (11) Patients less than 20 y.o. and/or more than 65 y.o. (12) Patient who have determined by their physicians to have any reason of unqualified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CDAI (Crohn's disease activity index) & IBDQ (a questionnaire for IBD patient) are evaluated at week 0,2,6,15(primary end-point),23(end). | — |
Secondary
| Measure | Time frame |
|---|---|
| CRP, Total-cholesterol, HDL/LDL-cholesterol, TG, and serum cytokines are evaluated at week 0,2,6,15(primary end-point),23(end). | — |
Countries
Japan
Contacts
Public ContactKen Fukunaga
Hyogo College of Medicine Department of lower gastroenterology
Outcome results
None listed