Atorvastatin in Patients With Ulcerative Colitis
- Registration Number
- NCT05561062
- Lead Sponsor
- Tanta University
- Brief Summary
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Age ≥ 18 years
- Both male and female will be included
- Negative pregnancy test and effective contraception
- 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 1 g mesalamine three times daily and 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 a short-form (SF-36) questionnaire. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.
- Secondary Outcome Measures
Name Time Method changes in the level of inflammatory biomarkers 6 months changes in the level of inflammatory biomarkers such as IL-6, fecal myeloperoxidase
Trial Locations
- Locations (1)
Faculty of Medicine, Mansoura University
🇪🇬Mansoura, Egypt