Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis
Phase 2
Recruiting
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Registration Number
- NCT05567068
- Lead Sponsor
- Tanta University
- Brief Summary
Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Age ≥ 18 years
- Both males and females will be included
- Negative pregnancy test and effective contraception.
Exclusion Criteria
- Breastfeeding
- Significant liver and kidney function abnormalities
- Colorectal cancer patients
- Patients with severe UC
- Patients taking rectal or systemic steroids
- Patients taking immunosuppressives or biological therapies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atorvastatin group Atorvastatin 80mg This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily. Control Group Mesalamine This group will take mesalamine 1 g three times daily Atorvastatin group Mesalamine This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.
- Primary Outcome Measures
Name Time Method Improvement in health related quality of life 6 months HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms
- Secondary Outcome Measures
Name Time Method changes in serum and fecal inflammatory biomarkers 6 months The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.
Trial Locations
- Locations (1)
Faculty of Medicine, Mansoura University
🇪🇬Mansoura, Egypt