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CompletedNCT05561062Updated Aug 11, 2025

Atorvastatin in Patients With Ulcerative Colitis

A Phase 2 interventional study of Atorvastatin 80mg in Inflammatory Bowel Diseases, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Inflammatory Bowel Diseases
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In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (actual)

Study arms

  • No intervention
    Control Group

    This group will take 1 g mesalamine three times daily

  • Active comparator
    Atorvastatin group

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

    Drug: Atorvastatin 80mg

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

06

What researchers measure

Primary outcomes

  1. Improvement in health related quality of life

    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.

    Time frame: 6 months

Secondary outcomes

  1. changes in the level of inflammatory biomarkers

    changes in the level of inflammatory biomarkers such as IL-6, fecal myeloperoxidase

    Time frame: 6 months

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Study locations

1 site
  • Faculty of Medicine, Mansoura University
    Al Mansurah, 35511, Egypt
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References and documents

Publications

  • Alarfaj SJ, El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Elmasry TA, Alrubia S, Alsegiani AS, Bahaa MM. Effect of a high dose atorvastatin as adjuvant therapy to mesalamine in attenuating inflammation and symptoms in patients with ulcerative colitis: a randomized controlled pilot study. Front Med (Lausanne). 2025 Jan 22;11:1490178. doi: 10.3389/fmed.2024.1490178. eCollection 2024. PubMed 39911672 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05561062
Lead sponsor
Tanta University
Responsible party
Mostafa Bahaa (Teaching Assistant, Tanta University) — Principal investigator
First posted
Sep 30, 2022
Start date
Dec 1, 2022
Primary completion
Nov 1, 2024
Completion
Nov 1, 2024
Last update
Aug 11, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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