Silymarin in NAFLD

Non-Alcoholic Fatty Liver Disease Clinical Trial

— SINF  

Official title:

Silymarin® - Efficacy in Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) Controlled by Laboratory and and Elastographic Parameters

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02973295
• Other study ID #: KBCRi/2016-GH01
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 20, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2020
• Source: University Hospital Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• Silymarin
Capsules contains 100 mg of silymarin

Other:
• Placebo Oral Capsule
Capsule will be identical in shape, size and color, packed in the same way like verum

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre	Rijeka	Kresimirova 42

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Rijeka	Belupo, University of Rijeka, Faculty of Health studies, University of Rijeka, Medical Faculty

Country where clinical trial is conducted

Croatia, 

References & Publications (4)

Festi D, Schiumerini R, Marzi L, Di Biase AR, Mandolesi D, Montrone L, Scaioli E, Bonato G, Marchesini-Reggiani G, Colecchia A. Review article: the diagnosis of non-alcoholic fatty liver disease -- availability and accuracy of non-invasive methods. Aliment Pharmacol Ther. 2013 Feb;37(4):392-400. doi: 10.1111/apt.12186. Epub 2012 Dec 20. Review. — View Citation

Mikolasevic I, Milic S, Orlic L, Stimac D, Franjic N, Targher G. Factors associated with significant liver steatosis and fibrosis as assessed by transient elastography in patients with one or more components of the metabolic syndrome. J Diabetes Complications. 2016 Sep-Oct;30(7):1347-53. doi: 10.1016/j.jdiacomp.2016.05.014. Epub 2016 May 20. — View Citation

Mikolasevic I, Orlic L, Franjic N, Hauser G, Stimac D, Milic S. Transient elastography (FibroScan(®)) with controlled attenuation parameter in the assessment of liver steatosis and fibrosis in patients with nonalcoholic fatty liver disease - Where do we stand? World J Gastroenterol. 2016 Aug 28;22(32):7236-51. doi: 10.3748/wjg.v22.i32.7236. Review. — View Citation

Mikolasevic I, Orlic L, Hrstic I, Milic S. Metabolic syndrome and non-alcoholic fatty liver disease after liver or kidney transplantation. Hepatol Res. 2016 Aug;46(9):841-52. doi: 10.1111/hepr.12642. Epub 2016 Feb 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Transient elastography detected by FibroScan®, Echosense, France	0 week (Initiation) and during 24-25 week (End of the Study)
Secondary	Change in liver enzymes in period of 6 months	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.	0 week (Initiation) and during 24-25 week (End of the Study)
Secondary	Change in insulin resistance in period of 6 months	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.)	0 week (Initiation) and during 24-25 week (End of the Study)
Secondary	Change in lipidogram in period of 6 months	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	0 week (Initiation) and during 24-25 week (End of the Study)