NCT02973295

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
2.8 years until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

November 4, 2016

Last Update Submit

November 3, 2020

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD;FibroscanSilymarin

Outcome Measures

Primary Outcomes (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

    Transient elastography detected by FibroScan®, Echosense, France

    0 week (Initiation) and during 24-25 week (End of the Study)

Secondary Outcomes (3)

  • Change in liver enzymes in period of 6 months

    0 week (Initiation) and during 24-25 week (End of the Study)

  • Change in insulin resistance in period of 6 months

    0 week (Initiation) and during 24-25 week (End of the Study)

  • Change in lipidogram in period of 6 months

    0 week (Initiation) and during 24-25 week (End of the Study)

Study Arms (2)

Group Silymarin

EXPERIMENTAL

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

Drug: Silymarin

Group Placebo

PLACEBO COMPARATOR

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

Other: Placebo Oral Capsule

Interventions

SilymarinDRUG

Capsules contains 100 mg of silymarin

Group Silymarin
Placebo Oral CapsuleOTHER

Capsule will be identical in shape, size and color, packed in the same way like verum

Also known as: no other names
Group Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NAFLD patients
  • signed informed consent
  • possibility to follow instruction and the protocol

You may not qualify if:

  • chronic B or C hepatitis
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Centre

Rijeka, Kresimirova 42, 51000, Croatia

Location

Related 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.

    PMID: 23278163BACKGROUND

  • Mikolasevic I, Orlic L, Franjic N, Hauser G, Stimac D, Milic S. Transient elastography (FibroScan((R))) 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.

    PMID: 27621571BACKGROUND

  • 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.

    PMID: 27324703BACKGROUND

  • 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.

    PMID: 26713425BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

FlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Goran Hauser, MD, PhD

    Clinical Hospital Centre Rijek, Croatia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Goran Hauser, Principal investigator

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 25, 2016

Study Start

September 20, 2019

Primary Completion

December 1, 2020

Study Completion

June 30, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

All patient data will be available to other researchers after interim analysis

Locations

CR(1)