Rutin Therapy Role in Reducing Ulcerative Colitis Severity

NCT07147842 | Completed

• 1 other identifier: RC 3.7.2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  3~4 Months

Study Arms (3)

Ulcerative Colitis-A (UC-A)

ACTIVE COMPARATOR

Patients diagnosed with active Ulcerative Colitis were assigned as group UC-A

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

Other: Placebo; Diagnostic Test: fecal calprotectin

Healthy Group (C)

ACTIVE COMPARATOR

Healthy volunteers provided samples as negative controls; and was assigned as group C

Diagnostic Test: fecal calprotectin

Interventions

Rutin 500 MG DRUG

Rutin 500 mg capsules twice daily for 30 days

Ulcerative Colitis-A (UC-A)

Placebo OTHER

Placebo Tablets

Ulcerative Colitis-B (UC-B)

fecal calprotectin DIAGNOSTIC_TEST

Fecal calprotectin level was measured using an ELISA kit .

Healthy Group (C); Ulcerative Colitis-A (UC-A); Ulcerative Colitis-B (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:

• Patients presenting with symptoms suggestive of IBD;
• Patients with positive microscopic mucosal changes consistent with UC.

You may not qualify if:

• Patients with the presence of recurrent ulceration after surgical treatment, malignancy, or autoimmune disorders.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Rutin

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physiology, Faculty of Medicine

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: November 1, 2024
• Primary Completion: January 8, 2025
• Study Completion: May 20, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

EG (1)