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NCT06213857Not yet recruiting

Beneficial Effect of Silymarin in Ulcerative Colitis

Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis
Tanta UniversityClinicalTrials.govdietary supplement
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
Silymarin
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Tanta University
Timeline & enrollment
Phase
N/A
Start date
Feb 01, 2024
End date
Mar 01, 2025
Enrollment
44 participants
Primary outcome

2 points or more decrease in the Mayo score from baseline

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 newly diagnosed 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 (4g\day induction & 2g\day
 maintenance) only for 6 months.
 
 - Group Ⅱ (silymarin group): 22 patients will receive mesalamine (4g\day induction &
 2g\day maintenance) and silymarin (140 mg\day) for 6 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.

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06213857
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06213857 through Pure Global AI's free database. This phase not specified trial is sponsored by Tanta University and is currently Not yet recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 44 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.