RecruitingPhase 2NCT06213857

Beneficial Effect of Silymarin in Ulcerative Colitis

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


Sponsor

Tanta University

Enrollment

44 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether silymarin — a natural compound extracted from milk thistle — can help reduce inflammation and improve symptoms in patients with ulcerative colitis (UC), a chronic inflammatory disease of the large intestine. Silymarin is known for its antioxidant and anti-inflammatory properties, and researchers want to see if it adds benefit alongside standard UC treatment. **You may be eligible if...** - You are 18 to 65 years old - You have been diagnosed with ulcerative colitis, confirmed by colonoscopy and lab tests - Your kidney and liver function are normal - You are willing to participate and sign a consent form **You may NOT be eligible if...** - You have a known allergy to silymarin or milk thistle - You are pregnant, breastfeeding, or a smoker - You are currently on corticosteroids or biologic medications for your UC - You have significant kidney or liver problems - You are taking other antioxidant supplements - You have another condition involving oxidative stress such as chronic liver disease or pulmonary infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTSilymarin

Silymarin (milk thistle), an extract obtained from Silybum marianum seeds containing a complex of flavonolignans with a potent intracellular antioxidant property. The first usage of Milk thistle was for its hepatoprotective and antioxidant activities, but in the recent years it has been used to control of immune based murine colitis by healing of bowel histology and reduction of bowel inflammatory cytokines especially TNF-α, interleukin-1β (IL-1β), and nuclear factor κB (NF-κB). Silymarin has anti-viral, immunomodulation, anti-inflammatory effects as well as antioxidant properties by scavenging free radicals and increasing the glutathione concentrations, protective and wound healing effects. It increases the gene expression of antioxidant enzymes and the number of the most important protection mechanisms against free-radicals damage containing superoxide dismutase (SOD), glutathione peroxidase (GPX), and catalase.

DRUGMesalamine

A 5-aminosalicylic acid compound used in the treatment of mild to moderate ulcerative colitis, with high rates of efficacy in induction and maintenance of remission.

DRUGAzathioprine

An immunosuppressive medication that is used for the treatment of inflammatory bowel disease (Crohn's disease and ulcerative colitis). It works by decreasing the activity of the body's immune system so it will not attack itself.


Locations(2)

Mabarra Hospital

Asyut, Egypt

Rajhy Hospital

Asyut, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06213857


Related Trials