Ulcerative ColitisPhase 2NCT07370220
Effect of Rutin on Inflammation Pathways in Ulcerative Colitis Patients
A Phase 2 study testing Rutin 500 MG Oral Tablet and Fecal Calprotectin in people with Ulcerative Colitis, run by Benha University at 1 site in Egypt.
Trial summary
This study evaluates the therapeutic role of Rutin (a plant-derived flavonoid) in reducing the severity of Ulcerative Colitis (UC). The study investigates whether Rutin can decrease intestinal inflammation and improve clinical symptoms by inhibiting the NLRP3 inflammasome signaling pathway, which is activated by… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Rutin 500 MG Oral Tablet and Fecal Calprotectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2025to 15 Nov 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of UC confirmed by endoscopy/histology.
- Age 18 to 65 years.
Who cannot join
- Pregnancy or breastfeeding.
- Known hypersensitivity to Rutin.
- Presence of other serious systemic diseases (e.g., malignancy, severe hepatic or renal failure).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rutin Therapy Reduces Ulcerative Colitis Disease Activity By Inhibiting The NOD-Like Receptor Protein 3 (NLRP3) Inflammasome: A Molecular Assessment in an Interventional Study.
This study evaluates the therapeutic role of Rutin (a plant-derived flavonoid) in reducing the severity of Ulcerative Colitis (UC). The study investigates whether Rutin can decrease intestinal inflammation and improve clinical symptoms by inhibiting the NLRP3 inflammasome signaling pathway, which is activated by oxidative stress in the colon.
- Conditions
- Ulcerative Colitis
- Being tested
- Rutin 500 MG Oral Tablet, Fecal Calprotectin, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rutin 500 MG Oral TabletDrug
Oral capsules twice daily for 30 days
Fecal CalprotectinDiagnostic test
Sample collection only for baseline comparison.
PlaceboDrug
Placebo tablets for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Active Ulcerative Colitis (UC-A) | Active comparator | Not described Receives: Drug: Rutin 500 MG Oral Tablet; Diagnostic Test: Fecal Calprotectin |
| Remission Ulcerative Colitis (UC-B) | Active comparator | Not described Receives: Diagnostic Test: Fecal Calprotectin; Drug: Placebo |
| Healthy Control (Group C) | Placebo comparator | Not described Receives: Diagnostic Test: Fecal Calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Clinical Improvement
The percentage of participants who achieve clinical improvement at the end of the treatment period. Clinical improvement is defined as reaching a score of 5 or less on the Simple Clinical Colitis Activity Index (SCCAI).
Measured: Day 30 (End of treatment)
Secondary outcomes (1)
Change in Fecal Calprotectin Levels
The concentration of Fecal Calprotectin measured in stool samples to quantify the reduction in intestinal inflammation.
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start22 Feb 2025
- Primary completion25 May 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Benha 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raafat R. Mohammed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370220
- Sponsor's protocol ID
- Rc 3.1.2025
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rutin Therapy Reduces Ulcerative Colitis Disease Activity By Inhibiting The NOD-Like Receptor Protein 3 (NLRP3) Inflammasome: A Molecular Assessment in an Interventional Study.
- ClinicalTrials.gov ID
- NCT07370220
- Acronym / sponsor ID
- Rc 3.1.2025
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 27 Jan 2026 (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.
This study evaluates the therapeutic role of Rutin (a plant-derived flavonoid) in reducing the severity of Ulcerative Colitis (UC). The study investigates whether Rutin can decrease intestinal inflammation and improve clinical symptoms by inhibiting the NLRP3 inflammasome signaling pathway, which is activated by oxidative stress in the colon.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Ulcerative Colitis (UC-A) | Active comparator | Drug: Rutin 500 MG Oral Tablet, Diagnostic Test: Fecal Calprotectin |
| Remission Ulcerative Colitis (UC-B) | Active comparator | Diagnostic Test: Fecal Calprotectin, Drug: Placebo |
| Healthy Control (Group C) | Placebo comparator | Diagnostic Test: Fecal Calprotectin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of UC confirmed by endoscopy/histology.
- Age 18 to 65 years.
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding.
- Known hypersensitivity to Rutin.
- Presence of other serious systemic diseases (e.g., malignancy, severe hepatic or renal failure).
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 |
|---|---|---|
| Rutin 500 MG Oral TabletOral capsules twice daily for 30 days | Drug | Active Ulcerative Colitis (UC-A) |
| Fecal CalprotectinSample collection only for baseline comparison. | Diagnostic test | Active Ulcerative Colitis (UC-A), Healthy Control (Group C), Remission Ulcerative Colitis (UC-B) |
| PlaceboPlacebo tablets for 30 days | Drug | Remission Ulcerative Colitis (UC-B) |
Primary outcome
Success Rate of Clinical Improvement
Time frame: Day 30 (End of treatment)
The percentage of participants who achieve clinical improvement at the end of the treatment period. Clinical improvement is defined as reaching a score of 5 or less on the Simple Clinical Colitis Activity Index (SCCAI).
1 secondary outcome
Change in Fecal Calprotectin Levels
Time frame: Baseline and Day 30
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 27 Jan 2026.
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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 Rutin 500 MG Oral Tablet and Fecal Calprotectin in people with Ulcerative Colitis, run by Benha 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 2 inclusion and 3 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 27 Jan 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. Some participants in this study may receive a placebo. 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?
Success Rate of Clinical Improvement (time frame: Day 30 (End of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.