Effect of Rutin on Inflammation Pathways in Ulcerative Colitis Patients

NCT07370220 | Completed Phase 2

• 1 other identifier: Rc 3.1.2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 oxidative stress in the colon.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 30 (End of treatment)

Secondary Outcomes (1)

• Change in Fecal Calprotectin Levels

  Baseline and Day 30

Study Arms (3)

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

Interventions

Rutin 500 MG Oral Tablet DRUG

Oral capsules twice daily for 30 days

Active Ulcerative Colitis (UC-A)

Fecal Calprotectin DIAGNOSTIC_TEST

Sample collection only for baseline comparison.

Active Ulcerative Colitis (UC-A); Healthy Control (Group C); Remission Ulcerative Colitis (UC-B)

Placebo DRUG

Placebo tablets for 30 days

Remission Ulcerative Colitis (UC-B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Faculty of Medicine

Banhā, Al Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Rutin; Tablets

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant consultant of Clinical Pathology

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: February 22, 2025
• Primary Completion: May 25, 2025
• Study Completion: November 15, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

EG (1)