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.
1 other identifier
interventional
54
1 country
1
Brief Summary
Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedNovember 18, 2025
November 1, 2025
2.3 years
October 1, 2022
November 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in health related quality of life
HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms
6 months
Secondary Outcomes (1)
changes in serum and fecal inflammatory biomarkers
6 months
Study Arms (2)
Control Group
OTHERThis group will take mesalamine 1 g three times daily
Atorvastatin group
ACTIVE COMPARATORThis group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.
Interventions
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
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Both males and females will be included
- Negative pregnancy test and effective contraception.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Faculty of Medicine, Mansoura University
Al Mansurah, 35511, Egypt
Related Publications (1)
Khrieba MO, Abdulelah FM, Alsaleh NA, AlRasheed HA, Ahmed TI, El-Sayed Mansy A, Hamouda MA, Habba E, Elshorbagi N, Abd Elhameed AG, Hamza E, Salahuddin MM, Mourad SA, Kamal M. Atorvastatin as an immunomodulatory adjunct in ulcerative colitis, beyond lipid lowering to inflammation control: a randomized controlled pilot study. Front Pharmacol. 2025 Oct 29;16:1690513. doi: 10.3389/fphar.2025.1690513. eCollection 2025.
PMID: 41235106DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- double-blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Assistant
Study Record Dates
First Submitted
October 1, 2022
First Posted
October 5, 2022
Study Start
February 1, 2023
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
November 18, 2025
Record last verified: 2025-11