Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Tanta University54 enrolled

Overview

Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inflammatory Bowel Diseases

Interventions

Atorvastatin 80mgDRUG

Atrovastatin 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

MesalamineDRUG

Mesalamine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

Improvement in health related quality of life

HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms

Time frame: 6 months

Secondary Outcomes

changes in serum and fecal inflammatory biomarkers

The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.

Time frame: 6 months

Data from ClinicalTrials.gov

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