Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2019-09-20
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group Silymarin
Silymarin 2x200 mg 8 weeks (2x2 caps) Silymarin 2x100 mg 16 weeks (2x1 caps)
Silymarin
Capsules contains 100 mg of silymarin
Group Placebo
2x2 placebo caps 8 weeks 2x1 placebo caps 16 weeks
Placebo Oral Capsule
Capsule will be identical in shape, size and color, packed in the same way like verum
Interventions
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Silymarin
Capsules contains 100 mg of silymarin
Placebo Oral Capsule
Capsule will be identical in shape, size and color, packed in the same way like verum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* signed informed consent
* possibility to follow instruction and the protocol
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Rijeka, Medical Faculty
UNKNOWN
Belupo
OTHER
University of Rijeka, Faculty of Health studies
UNKNOWN
University Hospital Rijeka
OTHER
Responsible Party
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Goran Hauser
Goran Hauser, Principal investigator
Principal Investigators
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Goran Hauser, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Hospital Centre Rijek, Croatia
Locations
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Clinical Hospital Centre
Rijeka, Kresimirova 42, Croatia
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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KBCRi/2016-GH01
Identifier Type: -
Identifier Source: org_study_id