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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis
• Intervention / Treatment: Drug: Fenofibrate; Drug: Silymarin

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Fenofibrate group	Drug: Fenofibrate; fenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days.
Experimental: Silymarin group	Drug: Silymarin; silymarin does ranged between (980 - 1120 mg) daily, in divided doses plus conventional sepsis therapy for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sepsis, fenofibrate, silymarin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ethers; Pyrans; Hydrocarbons; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Butyrates; Benzopyrans; Flavonoids; Chromones; Phenyl Ethers; Ketones; Fibric Acids; Isobutyrates; Benzophenones; Flavonolignans; Fenofibrate; Silymarin
• Other Study ID Numbers: 36265MD41030/1/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No