Effect of Rutin on Inflammation Pathways in Ulcerative Colitis Patients

January 19, 2026 updated by: Raafat R. Mohammed, Benha University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qalyoubia
      • Banhā, Al Qalyoubia, Egypt, 13511
        • Benha Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of UC confirmed by endoscopy/histology.
  • Age 18 to 65 years.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Known hypersensitivity to Rutin.
  • Presence of other serious systemic diseases (e.g., malignancy, severe hepatic or renal failure).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Ulcerative Colitis (UC-A)
Drug: Rutin 500 MG Oral Tablet
Oral capsules twice daily for 30 days
Diagnostic test: Fecal Calprotectin
Sample collection only for baseline comparison.
Active Comparator: Remission Ulcerative Colitis (UC-B)
Diagnostic test: Fecal Calprotectin
Sample collection only for baseline comparison.
Drug: Placebo
Placebo tablets for 30 days
Placebo Comparator: Healthy Control (Group C)
Diagnostic test: Fecal Calprotectin
Sample collection only for baseline comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 30 (End of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fecal Calprotectin Levels
Time Frame: Baseline and Day 30
The concentration of Fecal Calprotectin measured in stool samples to quantify the reduction in intestinal inflammation.
Baseline and Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2025

Primary Completion (Actual)

May 25, 2025

Study Completion (Actual)

November 15, 2025

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc 3.1.2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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