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Silymarin in NAFLD (SINF)

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ClinicalTrials.gov Identifier: NCT02973295
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : October 29, 2019
Sponsor:
Collaborators:
University of Rijeka, Medical Faculty
Belupo
University of Rijeka, Faculty of Health studies
Information provided by (Responsible Party):
Goran Hauser, 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

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Drug: Silymarin Other: Placebo Oral Capsule Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Silymarin® - Efficacy in Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) Controlled by Laboratory and and Elastographic Parameters
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: Group Silymarin
Silymarin 2x200 mg 8 weeks (2x2 caps) Silymarin 2x100 mg 16 weeks (2x1 caps)
Drug: Silymarin
Capsules contains 100 mg of silymarin

Placebo Comparator: Group Placebo
2x2 placebo caps 8 weeks 2x1 placebo caps 16 weeks
Other: Placebo Oral Capsule
Capsule will be identical in shape, size and color, packed in the same way like verum
Other Name: no other names




Primary Outcome Measures :
  1. 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 [ Time Frame: 0 week (Initiation) and during 24-25 week (End of the Study) ]
    Transient elastography detected by FibroScan®, Echosense, France


Secondary Outcome Measures :
  1. Change in liver enzymes in period of 6 months [ Time Frame: 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.

  2. Change in insulin resistance in period of 6 months [ Time Frame: 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.)

  3. Change in lipidogram in period of 6 months [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973295


Contacts
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Contact: Goran Hauser, MD, PhD 385 98182072 goran.hauser@uniri.hr
Contact: Ivana Mikolasevic, MD, PhD ivana.mikolasevic@gmail.com

Locations
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Croatia
Clinical Hospital Centre Recruiting
Rijeka, Kresimirova 42, Croatia, 51000
Contact: Goran Hauser, MD, PhD    385 98 18 20 726    goran.hauser@medri.uniri.hr   
Contact: Patricia Mikic, ass    385 51 658 122    interna-rijeka@kbc-rijeka.hr   
Principal Investigator: Goran Hauser, MD,PhD         
Sponsors and Collaborators
University Hospital Rijeka
University of Rijeka, Medical Faculty
Belupo
University of Rijeka, Faculty of Health studies
Investigators
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Principal Investigator: Goran Hauser, MD, PhD Clinical Hospital Centre Rijek, Croatia

Publications:
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Responsible Party: Goran Hauser, Goran Hauser, Principal investigator, University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT02973295    
Other Study ID Numbers: KBCRi/2016-GH01
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All patient data will be available to other researchers after interim analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Goran Hauser, University Hospital Rijeka:
NAFLD;
Fibroscan
Silymarin
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs