Silymarin in NAFLD

Phase 4

Withdrawn

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: Silymarin; Other: Placebo Oral Capsule

• Registration Number: NCT02973295
• Lead Sponsor: University Hospital Rijeka

Brief Summary

This study evaluates the influence of Silymarin in reducing laboratory, ultrasonographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive Silymarin (Verum) while the other half will receive placebo

Detailed Description

In this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, nephrologists or family physicians in the Department of Gastroenterology and Department of Nephrology, dialysis and kidney transplantation KBC Rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP) for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis. In all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease.

This study will include 350 patients. Taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. Patients will be randomized into two groups. The first group will be consisted of the patients with NAFLD who will be receiving Verum therapy during the 6 month period. The second group will be consisted of the patients with NAFLD who will be receiving placebo during the 6 months period, which will be identical to the Verum preparation in its packaging and form.

After the 6 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose), as well as the TE-CAP in order to evaluate the efficiency of Silymarin for the treatment of NAFLD.

Study Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-25
• Study Start: 2019-09-20
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05
• Primary Completion: 2020-12
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• NAFLD patients
• signed informed consent
• possibility to follow instruction and the protocol

Exclusion Criteria

• chronic B or C hepatitis
• usage of hepatotoxic drugs in the period of 6 months before inclusion
• chronic kidney insufficiency (grade 4 and 5), hemodialysis
• any other chronic liver disease
• opioid dependancy
• any malignancy
• HIV seropositivity
• alcohol abuse
• pregnancy
• inability to follow the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Silymarin	Silymarin	Silymarin 2x200 mg 8 weeks (2x2 caps) Silymarin 2x100 mg 16 weeks (2x1 caps)
Group Placebo	Placebo Oral Capsule	2x2 placebo caps 8 weeks 2x1 placebo caps 16 weeks

Primary Outcome Measures

Name	Time	Method
Change (Reduction) of parameters of liver steatosis defined by CAP (Controlled Attenuation Parameter) and liver fibrosis defined by LSM (liver stiffness measurements) during the 6 months period	0 week (Initiation) and during 24-25 week (End of the Study)	Transient elastography detected by FibroScan®, Echosense, France

Secondary Outcome Measures

Name	Time	Method
Change in liver enzymes in period of 6 months	0 week (Initiation) and during 24-25 week (End of the Study)	AST (Aspartate Aminotransferase ) ALT (alanine aminotransferase), GGT (gamma-glutamyltransferase), ALP (Alkaline Phosphatase). All outcomes have the same units of measure (UI/L) and all together represents liver function test.
Change in insulin resistance in period of 6 months	0 week (Initiation) and during 24-25 week (End of the Study)	In the assessment of the insulin resistance HOMA-IR scoring system will be used (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.)
Change in lipidogram in period of 6 months	0 week (Initiation) and during 24-25 week (End of the Study)	lipidogram (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) All outcomes have the same units of measure (umol/L) and all together represents lipid profile

Trial Locations

Locations (1)

Clinical Hospital Centre; 🇭🇷 Rijeka, Kresimirova 42, Croatia