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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adults of both sexes aged from 18 years to 65 years.

• Adults with normal kidney and liver functions.

• Patients who sign the consent and willing to participate in the study.

• Patients with UC according to American College of Gastroenterology Clinical Guidelines for diagnosis Ulcerative Colitis having clinical signs and symptoms with a completed medical workup, colonoscopy, pathological and laboratory data confirming UC

Locations
Other Locations
Egypt
Mabarra Hospital
RECRUITING
Asyut
Rajhy Hospital
RECRUITING
Asyut
Contact Information
Primary
Ahmad A Ahmad Eltayeb, Cl.Ph
PG_165473@pharm.tanta.edu.eg
+201140399467
Backup
Dalia R Mohammed ElAfify, Asst.Prof
dalia.mohamed1@pharm.tanta.edu.eg
+201006831093
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 44
Treatments
Active_comparator: A (Control group)
Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months
Experimental: B (Silymarin group)
Mesalamine (2g/day) + Azathioprine (50mg/day) + Silymarin (140mg/day) for 3 months
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov