Beneficial Effect of Silymarin in Ulcerative Colitis

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.

Conditions

• Ulcerative Colitis

Interventions

DIETARY_SUPPLEMENT

Silymarin

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.

DRUG

Mesalamine

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.

DRUG

Azathioprine

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.

Sponsors & Collaborators

• Tanta University

  lead OTHER

Principal Investigators

• Sahar M Ghobashy ElHaggar, Professor · Tanta University

• Hussein A ElAmin Hammam, Professor · Assiut University

• Dalia R Mohammed ElAfify, Asst.Prof · Tanta University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2025-05-31

Completion

2025-06-30

Countries

• Egypt

Study Locations