Atorvastatin in Patients With Ulcerative Colitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05561062

Enrollment

Registered

2022-09-30

Start date

2022-12-01

Completion date

2024-11-01

Last updated

2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

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.

Interventions

DRUGAtorvastatin 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

double-blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
changes in the level of inflammatory biomarkers	6 months	changes in the level of inflammatory biomarkers such as IL-6, fecal myeloperoxidase

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026