Effect of Rutin on Inflammation Pathways in Ulcerative Colitis Patients

Benha University

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Rutin 500 MG Oral Tablet; Drug: Placebo; Diagnostic Test: Fecal Calprotectin

Study type: Interventional

Funder types: Other

Identifiers

NCT07370220

Rc 3.1.2025

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups, including a placebo group

Active Ulcerative Colitis (UC-A)

Active Comparator group

Treatment:

Diagnostic Test: Fecal Calprotectin

Drug: Rutin 500 MG Oral Tablet

Remission Ulcerative Colitis (UC-B)

Active Comparator group

Treatment:

Drug: Placebo

Diagnostic Test: Fecal Calprotectin

Healthy Control (Group C)

Placebo Comparator group

Treatment:

Diagnostic Test: Fecal Calprotectin