Silymarin in NAFLD (SINF)

University Hospital Rijeka

Status and phase: Withdrawn; Phase 4

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Other: Placebo Oral Capsule; Drug: Silymarin

Study type: Interventional

Funder types: Other

Identifiers

NCT02973295

KBCRi/2016-GH01

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Group Silymarin

Experimental group

Description:

Silymarin 2x200 mg 8 weeks (2x2 caps) Silymarin 2x100 mg 16 weeks (2x1 caps)

Treatment:

Drug: Silymarin

Group Placebo

Placebo Comparator group

Description:

2x2 placebo caps 8 weeks 2x1 placebo caps 16 weeks

Treatment:

Other: Placebo Oral Capsule