Back to resultsAtorvastatin in Patients With Ulcerative Colitis
Primary Purpose
Inflammatory Bowel Diseases
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin 80mg
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Atorvastatin group
Arm Description
This group will take 1 g mesalamine three times daily
This group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
changes in the level of inflammatory biomarkers
changes in the level of inflammatory biomarkers such as IL-6, fecal myeloperoxidase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05561062
Brief Title
Atorvastatin in Patients With Ulcerative Colitis
Official Title
Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
June 20, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
double-blinded
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will take 1 g mesalamine three times daily
Arm Title
Atorvastatin group
Arm Type
Active Comparator
Arm Description
This group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in health related quality of life
Description
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 Outcome Measure Information:
Title
changes in the level of inflammatory biomarkers
Description
changes in the level of inflammatory biomarkers such as IL-6, fecal myeloperoxidase
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
Facility Information:
Facility Name
Faculty of Medicine, Mansoura University
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa M Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
12. IPD Sharing Statement
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Atorvastatin in Patients With Ulcerative Colitis
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