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Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05567068
Enrollment
54
Registered
2022-10-05
Start date
2023-02-01
Completion date
2025-06-01
Last updated
2025-11-18

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

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

Interventions

DRUGAtorvastatin 80mg

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

DRUGMesalamine

Mesalamine

Sponsors

Tanta University
Lead SponsorOTHER

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
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in health related quality of life6 monthsHRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms

Secondary

MeasureTime frameDescription
changes in serum and fecal inflammatory biomarkers6 monthsThe secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.

Countries

Egypt

Outcome results

None listed

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