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OpenTrials
Completed

NCT Number: NCT05567068

Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

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

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Mansoura University

Al Mansurah, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin 80mg

Drug

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

Mesalamine

Drug

Mesalamine

Primary outcomes

  1. Improvement in health related quality of life

    Time frame: 6 months

    HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms

Secondary outcomes

  1. changes in serum and fecal inflammatory biomarkers

    Time frame: 6 months

    The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2022
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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