Inflammatory Bowel DiseasesPhase 2NCT05561062
Atorvastatin in Patients With Ulcerative Colitis
A Phase 2 study testing Atorvastatin 80mg in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Atorvastatin 80mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Both male and female will be included
- Negative pregnancy test and effective contraception
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Atorvastatin 80mg
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80mgDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will take 1 g mesalamine three times daily |
| Atorvastatin group | Active comparator | This group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily Receives: Drug: Atorvastatin 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Jan 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561062
- Sponsor's protocol ID
- 9/22021
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05561062
- Acronym / sponsor ID
- 9/22021
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will take 1 g mesalamine three times daily |
| Atorvastatin group | Active comparator | Drug: Atorvastatin 80mgThis group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Both male and female will be included
- Negative pregnancy test and effective contraception
Key exclusion criteria (6 listed)
- Breastfeeding
- Significant liver and kidney function abnormalities
- Colorectal cancer patients
- Patients with severe UC
- Patients taking rectal or systemic steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 80mgAtorvastatin 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 | Drug | Atorvastatin group |
Primary outcome
Improvement in health related quality of life
Time frame: 6 months
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.
1 secondary outcome
changes in the level of inflammatory biomarkers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 39911672Alarfaj 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.
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Ulcerative Colitis (UC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 80mg in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in health related quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.