Silymarin Added to Standard Treatment for Ulcerative Colitis
Tests silymarin with usual drugs in adults with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Beneficial Effect of Silymarin in Ulcerative Colitis
Key facts
- Where
- Asyut, EgyptSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06213857, who can take part
Where in Egypt
- Mabarra HospitalAsyut, EgyptTaking people
- Rajhy HospitalAsyut, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tanta University
- Trial code
- NCT06213857
- Record updated
- 5 March 2025
- Original description
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.Read full original descriptionShow less
Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis
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.
Inclusion: 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.
Exclusion: Previous hypersensitivity or anaphylactic reaction to silymarin; Patients taking corticosteroids or biological therapy; Patients having other concomitant diseases where oxidative stress is involved in the etiology such as chronic liver disease, pulmonary infection; Significant renal and hepatic impairment; Patients who refuse to participate; Pregnant women, breastfeeding women and smokers; Patients taking any other antioxidants.