Silymarin for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring non-alcoholic fatty liver disease, sillymarin, randomised trial, non-alcoholic steatohepatitis Read More

Inclusion Criteria:

• Male or female 18 years of age or older.
• Diagnosed with NASH (refer to Section 5.2)
• AST and/or ALT greater than 40 IU/L.
• Must agree to adhere to alcohol consumption guideline.
• Weight gain//loss of no more than 10% between biopsy and screening or within 30 days of screening if the biopsy is performed during the screening period.
• No change in diabetic and/or lipid medications between biopsy and screening or within 30 days of screening if the biopsy is performed during the screening period

Exclusion Criteria:

• Use of silymarin or other milk thistle preparations for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period.

  • Use of other antioxidants or non-prescribed complementary alternative medications for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period.
  • Use of warfarin, metronidazole, or acetaminophen (greater than 2 grams per day) between screening and randomization.
  • Use of oral steroids for more than 14 days of screening or prior to randomization.
  • BMI ≥ 35 kg/m2 between screening and randomization.
  • Poorly-controlled diabetes (HbA1c > 8 %) between screening and randomization
  • Diabetes mellitus treated with oral agents other than the secretagogues or metformin between screening and randomization. Sitagliptin is allowed.
  • For patients using anti-hyperlipidemic agents or accepted anti-diabetic agents, any change of agent or dose between screening and randomization.
  • Radiologic imaging consistent with cirrhosis or portal hypertension.
  • Evidence of decompensated liver disease
  • Platelet count < 130 x 109 /L at screening.
  • History of bariatric surgery, or undergoing evaluation for bariatric surgery.
  • Known allergy/sensitivity to milk thistle or its preparations.
  • History of immunologically mediated disease
  • History of thyroid disease poorly controlled on prescribed medications.
  • History of solid organ or bone marrow transplantation.
  • Primary hepatic malignancy.
  • Secondary hepatic malignancy or extrahepatic malignancy.
  • Serum Creatinine of 176 μmol/L or greater or creatinine clearance (calculated according to Cockcroft-Gault) 60 mL/min or less, or on dialysis, at screening.
  • Severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study.
  • Women with ongoing pregnancy or breast feeding, or contemplating pregnancy.
  • Women of childbearing potential who are not practicing an acceptable form of birth control.
  • Participation in a research drug trial within 30 days of screening.
  • Inability or unwillingness to give informed consent or abide by the study protocol.