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Clinical trial

Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis

ID
Name
9/22021
Description
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.
Trial arms
Trial start
2022-12-01
Estimated PCD
2026-11-01
Trial end
2027-06-20
Status
Recruiting
Phase
Early phase I
Treatment
Atorvastatin 80mg
Atorvastatin is one of the most effective drugs used to reduce intracellular cholesterol synthesis. it exerts numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of its basic lipid-lowering properties
Arms:
Atorvastatin group
Size
50
Primary endpoint
Improvement in health related quality of life
6 months
Eligibility criteria
Inclusion Criteria: * Age ≥ 18 years * Both male and female 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double-blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-10

1 organization

1 product

1 indication

Organization
Tanta University
Product
Atorvastatin
Indication
Inflammatory Bowel Disease