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
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Fatty Liver Disease||Drug: Silymarin Other: Placebo Oral Capsule||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Experimental: Group Silymarin
Silymarin 2x200 mg 8 weeks (2x2 caps) Silymarin 2x100 mg 16 weeks (2x1 caps)
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
- 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
- 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.
- 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.)
- 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
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
|Contact: Goran Hauser, MD, PhD||385 email@example.com|
|Contact: Ivana Mikolasevic, MD, PhDfirstname.lastname@example.org|
|Clinical Hospital Centre||Recruiting|
|Rijeka, Kresimirova 42, Croatia, 51000|
|Contact: Goran Hauser, MD, PhD 385 98 18 20 726 email@example.com|
|Contact: Patricia Mikic, ass 385 51 658 122 firstname.lastname@example.org|
|Principal Investigator: Goran Hauser, MD,PhD|
|Principal Investigator:||Goran Hauser, MD, PhD||Clinical Hospital Centre Rijek, Croatia|