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NOT YET RECRUITING
NCT07863648
PHASE3

Vitamin E Versus Silymarin in Non Diabetic MASLD Patients

Sponsor: Kafrelsheikh University

View on ClinicalTrials.gov

Summary

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), is a chronic liver condition marked by excessive fat buildup (steatosis) in liver cells, linked to at least one metabolic risk factor like obesity, type 2 diabetes, high blood lipids, or hypertension. Vitamin E serves as a recommended antioxidant therapy for select MASLD patients. It reduces liver inflammation markers such as ALT and AST, alongside benefits in steatosis and MASH resolution. Silymarin has clinical evidence supports its use as an adjunctive hepatoprotective agent due to antioxidant, anti-inflammatory, and antifibrotic effects.

Official title: A Randomized Controlled Evaluation of Vitamin E Versus Silymarin on Liver Through Modulation of mRNA Profiles, NLRP3 Inflammasome Signaling, and Oxidative Stress in Non Diabetic MASLD Patients

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-16

Completion Date

2027-09-01

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DRUG

Vitamin E 800 IU/d

Participants in Vitamin E Group will receive oral vitamin E at dose of 800 IU/d for a total duration of 24 weeks

DRUG

Silymarin 420 mg

Participants in Silymarin Group will receive oral silymarin at dose of 420 mg/d for a total duration of 24 weeks

DRUG

Placebo

participants in Placebo Group will receive an oral placebo capsule, identical in appearance to the active interventions once daily for 24 weeks

Locations (1)

Faculty of Medicine

Tanta, Egypt