Atorvastatin in Patients With Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Atorvastatin 80mg

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2022-12-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2026-11-01
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥ 18 years
• Both male and female will be included
• Negative pregnancy test and effective contraception

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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

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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