Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis

NCT06213857 Phase 2 RECRUITING

The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians. Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups: * Group Ⅰ (Control group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months. * Group Ⅱ (Silymarin group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) + Silymarin (140 mg/day) for 3 months. The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.

Details

Lead sponsor	Tanta University
Phase	Phase 2
Status	RECRUITING
Enrolment	44
Start date	2025-02-01
Completion	2025-06

Conditions

• Ulcerative Colitis

Interventions

• Silymarin
• Mesalamine
• Azathioprine

Primary outcomes

• 2 points or more decrease in the Mayo score from baseline — baseline, 3 months
  The Mayo score is one of the most commonly used disease activity indices in controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.

Countries

Egypt