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Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized tria

Phase 2
Conditions
Crohn&#39
s disease
Registration Number
JPRN-UMIN000002074
Lead Sponsor
Department of lower gastroenterology, Hyogo College of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
CRP, Total-cholesterol, HDL/LDL-cholesterol, TG, and serum cytokines are evaluated at week 0,2,6,15(primary end-point),23(end).
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