Ulcerative ColitisNCT07147842
Rutin Therapy Role in Reducing Ulcerative Colitis Severity
A study testing Rutin 500 MG and fecal calprotectin in people with Ulcerative Colitis, run by Benha University at 1 site in Egypt.
Trial summary
Ulcerative colitis (UC) is an inflammatory bowel disease characterized by oxidative stress and recurring inflammation in the colon. The condition can become chronic, spread, and lead to other complications. A key player in the inflammation process is the NLRP3 inflammasome. 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 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
- 1 Nov 2024to 20 May 2025
- Phase
- Interventional
- 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
- Patients presenting with symptoms suggestive of IBD;
- Patients with positive microscopic mucosal changes consistent with UC.
Who cannot join
- Patients with the presence of recurrent ulceration after surgical treatment, malignancy, or autoimmune disorders.
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 a Case-Control Study
Ulcerative colitis (UC) is an inflammatory bowel disease characterized by oxidative stress and recurring inflammation in the colon. The condition can become chronic, spread, and lead to other complications.
A key player in the inflammation process is the NLRP3 inflammasome. This inflammasome's expression is heightened and activated by reactive oxygen species (ROS). Its activity is influenced by various factors, including the ubiquitin system, ion channels, and gut microbiota.
Rutin, a compound found in many fruits and vegetables, has been shown to have properties that help scavenge free radicals.
- Conditions
- Ulcerative Colitis
- Being tested
- Rutin 500 MG, Placebo, fecal calprotectin
- 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 MGDrug
Rutin 500 mg capsules twice daily for 30 days
PlaceboOther
Placebo Tablets
fecal calprotectinDiagnostic test
Fecal calprotectin level was measured using an ELISA kit .
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis-A (UC-A) | Active comparator | Patients diagnosed with active Ulcerative Colitis were assigned as group UC-A Receives: Drug: Rutin 500 MG; Diagnostic Test: fecal calprotectin |
| Ulcerative Colitis-B (UC-B) | Active comparator | Patients diagnosed with remission Ulcerative Colitis were assigned as control group UC-B Receives: Other: Placebo; Diagnostic Test: fecal calprotectin |
| Healthy Group (C) | Active comparator | Healthy volunteers provided samples as negative controls; and was assigned as group C 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 Treatment Regimens in improving the ulcerative colitis.
The proportion of patients who achieved a Simple Clinical Colitis Activity Index (SCCAI) score of 5 or less at the end of the study, which reflects the effectiveness of the treatment.
Measured: 3~4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Nov 2024
- Primary completion8 Jan 2025
- Study completion20 May 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.
- 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 N/A
- 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, Afnan El Gindy, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147842
- Sponsor's protocol ID
- RC 3.7.2025
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- 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 29 Aug 2025. 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 a Case-Control Study
- ClinicalTrials.gov ID
- NCT07147842
- Acronym / sponsor ID
- RC 3.7.2025
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 29 Aug 2025 (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 inflammatory bowel disease characterized by oxidative stress and recurring inflammation in the colon. The condition can become chronic, spread, and lead to other complications.
A key player in the inflammation process is the NLRP3 inflammasome. This inflammasome's expression is heightened and activated by reactive oxygen species (ROS). Its activity is influenced by various factors, including the ubiquitin system, ion channels, and gut microbiota.
Rutin, a compound found in many fruits and vegetables, has been shown to have properties that help scavenge free radicals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis-A (UC-A) | Active comparator | Drug: Rutin 500 MG, Diagnostic Test: fecal calprotectinPatients diagnosed with active Ulcerative Colitis were assigned as group UC-A |
| Ulcerative Colitis-B (UC-B) | Active comparator | Other: Placebo, Diagnostic Test: fecal calprotectinPatients diagnosed with remission Ulcerative Colitis were assigned as control group UC-B |
| Healthy Group (C) | Active comparator | Diagnostic Test: fecal calprotectinHealthy volunteers provided samples as negative controls; and was assigned as group C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting with symptoms suggestive of IBD;
- Patients with positive microscopic mucosal changes consistent with UC.
Key exclusion criteria (1 listed)
- Patients with the presence of recurrent ulceration after surgical treatment, malignancy, or autoimmune disorders.
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 MGRutin 500 mg capsules twice daily for 30 days | Drug | Ulcerative Colitis-A (UC-A) |
| PlaceboPlacebo Tablets | Other | Ulcerative Colitis-B (UC-B) |
| fecal calprotectinFecal calprotectin level was measured using an ELISA kit . | Diagnostic test | Healthy Group (C), Ulcerative Colitis-A (UC-A), Ulcerative Colitis-B (UC-B) |
Primary outcome
Success Rate of Treatment Regimens in improving the ulcerative colitis.
Time frame: 3~4 Months
The proportion of patients who achieved a Simple Clinical Colitis Activity Index (SCCAI) score of 5 or less at the end of the study, which reflects the effectiveness of the treatment.
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 29 Aug 2025.
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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 study testing Rutin 500 MG 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 1 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 29 Aug 2025. 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.
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 Treatment Regimens in improving the ulcerative colitis. (time frame: 3~4 Months). 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 29 Aug 2025.