Beneficial Effect of Silymarin in Ulcerative Colitis

NCT06213857 | Recruiting Phase 2

• 1 other identifier: Silymarin in UC
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 2 points or more decrease in the Mayo score from baseline

  The Mayo score is one of the most commonly used disease activity indices in controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.

  baseline, 3 months

Secondary Outcomes (3)

• The change in the level of fecal calprotectin

  baseline, 3 months

• The change in the level of superoxide dismutase

  baseline, 3 months

• The change in the level of TNF-α.

  baseline, 3 months

Study Arms (2)

A (Control group)

ACTIVE COMPARATOR

Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months

Drug: Mesalamine; Drug: Azathioprine

B (Silymarin group)

EXPERIMENTAL

Mesalamine (2g/day) + Azathioprine (50mg/day) + Silymarin (140mg/day) for 3 months

Dietary Supplement: Silymarin; Drug: Mesalamine; Drug: Azathioprine

Interventions

Silymarin DIETARY_SUPPLEMENT

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.

Also known as: Milk Thistle

B (Silymarin group)

Mesalamine DRUG

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.

Also known as: Mesalazine

A (Control group); B (Silymarin group)

Azathioprine DRUG

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.

Also known as: Immuran

A (Control group); B (Silymarin group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous hypersensitivity or anaphylactic reaction to silymarin.
• Significant renal and hepatic impairment.
• Patients who refuse to participate.
• Pregnant women, breastfeeding women and smokers.
• Patients taking corticosteroids or biological therapy.
• Patients taking any other antioxidants.
• Patients having other concomitant diseases where oxidative stress is involved in the etiology such as chronic liver disease, pulmonary infection.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Mabarra Hospital

Asyut, 71511, Egypt

RECRUITING

Rajhy Hospital

Asyut, 71511, Egypt

RECRUITING

Related Links

• A comparative study of curcumin-loaded lipid-based nanocarriers in the treatment of inflammatory bowel disease
• Inflammatory bowel disease: cause and immunobiology
• Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences
• A decade of inflammatory bowel disease: a single center experience in Egypt
• ACG Clinical Guideline: Ulcerative Colitis in Adults
• British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults
• Effect of silymarin on kidneys of rats suffering from alloxan-induced diabetes mellitus
• A Meta-Analysis of the Placebo Rates of Remission and Response in Clinical Trials of Active Ulcerative Colitis
• A randomized, double blinded, placebo-controlled clinical trial of silymarin in ulcerative colitis

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Silymarin; milk-thistle extract; Mesalamine; Azathioprine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sahar M Ghobashy ElHaggar, Professor

  Tanta University

  STUDY DIRECTOR

• Hussein A ElAmin Hammam, Professor

  Assiut University

  STUDY DIRECTOR

• Dalia R Mohammed ElAfify, Asst.Prof

  Tanta University

  STUDY CHAIR

Central Study Contacts

Ahmad A Ahmad Eltayeb, Cl.Ph

CONTACT

+201140399467; PG_165473@pharm.tanta.edu.eg

Dalia R Mohammed ElAfify, Asst.Prof

CONTACT

+201006831093; dalia.mohamed1@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: This is a randomized parallel study 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 (50 mg/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.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

EG (2)