Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Tanta University

Status and phase: Completed; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Mesalamine; Drug: Atorvastatin 80mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05567068

3433

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Control Group

Other group

Description:

This group will take mesalamine 1 g three times daily

Treatment:

Drug: Mesalamine

Atorvastatin group

Active Comparator group

Description:

This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.

Treatment:

Drug: Atorvastatin 80mg

Drug: Mesalamine