Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With Sepsis

NCT07572552 | Not Yet Recruiting Phase 2

• 1 other identifier: 36265MD41030/1/26
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sepsis is a life-threatening condition defined by organ dysfunction resulting from the body's dysregulated response to an infection (1). It begins with widespread inflammation and cellular damage, which quickly escalates into total circulatory failure and the breakdown of essential organ systems, including the lungs, kidneys, digestive tract, and brain. This study aims at evaluating the safety and efficacy of fenofibrate versus silymarin for adult patients with sepsis.

Conditions

Sepsis

Keywords

Sepsis, fenofibrate, silymarin

Outcome Measures

Primary Outcomes (1)

• change in the measured biological markers (TNF-α, MDA, and IL-10)

  change in the measured biological markers (TNF-α, MDA, and IL-10)

  after seven days

Study Arms (3)

Control group

NO INTERVENTION

Fenofibrate group

EXPERIMENTAL

Drug: Fenofibrate

Silymarin group

EXPERIMENTAL

Drug: Silymarin

Interventions

Fenofibrate DRUG

fenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days.

Fenofibrate group

Silymarin DRUG

silymarin does ranged between (980 - 1120 mg) daily, in divided doses plus conventional sepsis therapy for 7 days.

Silymarin group

Eligibility Criteria

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

You may qualify if:

• Adult age ≥18 years old. Both male and female patients. Patients diagnosed with sepsis regardless of its etiology, according to the definitions of the Surviving Sepsis Campaign (SSC)

You may not qualify if:

• Late septic shock at presentation with multiple organ failure. Serious gastrointestinal disease. Preexisting end-stage liver disease. Preexisting end-stage renal disease. Pregnant and breastfeeding women. History of allergy or intolerance to fenofibrate or silymarin. Patients with malignancies. Uncontrolled hemorrhage. Patients on immunosuppressant or biological therapies.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Sepsis

Interventions

Fenofibrate; Silymarin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

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

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share