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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomised study to examine whether high dose Sillymarin will be able to help improve fat-induced liver damage in the liver. The study hypothesis is that high dose Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better than placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya
• Collaborator: Rottapharm
• Treatments: Silymarin

Criteria

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.