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Completed

NCT Number: NCT07370220

Effect of Rutin on Inflammation Pathways in Ulcerative Colitis Patients

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Benha Faculty of Medicine

Banhā, Al Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rutin 500 MG Oral Tablet

Drug

Oral capsules twice daily for 30 days

fecal calprotectin

Diagnostic Test

Sample collection only for baseline comparison.

Placebo

Drug

Placebo tablets for 30 days

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Rutin Therapy Reduces Ulcerative Colitis Disease Activity By Inhibiting The NOD-Like Receptor Protein 3 (NLRP3) Inflammasome: A Molecular Assessment in an Interventional Study.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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