Patients will receive 2 capsules containing a total of 700mg of silymarin, 8mg of vitamin E and 50mg of phosphatidylcholine, in addition to the excipient, which should be ingested daily for 12 weeks.

Patients will also receive similarly 2 capsules per day, but without the bioactive principle tested (silymarin). Therefore, the capsules in the control group will contain only 700 mg of maltodextrin, a neutral food component derived from starch, in addition to the excipient and the same amount of vitamin E and phosphatidylcholine to balance the two groups.

Non-Alcoholic Fatty Liver Disease

It is a randomized, double-blind, controlled clinical trial to be performed at outpatient level. The intervention will last 12 weeks and the invited participants will be patients attended at the outpatient clinic of the Edgard Santos Hospital, which will be randomized into two groups: control and intervention. Data on laboratory and clinical markers, imaging, nutritional and dietary assessment, and physical activity level will be collected at the beginning and end of the trial for comparison purposes.

Silymarin

Camila Ribeiro de Avelar

Effect of Silymarin in Patients With Non-alcoholic Fatty Liver Disease

Effect of Silymarin on Clinical Evolution and Nutritional Variables of Patients With Non-alcoholic Fatty Liver Disease: Randomized Clinical Trial

Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L before and after intervention.

Serum ferritin will be evaluated in µg/L before and after intervention.

Total cholesterol (mg/dL), LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL), VLDL-cholesterol (mg/dL) and triglycerides (mg/dL) will be measured before and after the intervention.

Fasting blood glucose (mg/dL) will be measured before and after the intervention.

Hb A1c (%) will be measured before and after the intervention.

Insulin (µU/mL) will be measured before and after the intervention.

Serum iron (mcg/dL) will be measured before and after intervention.

Transferrin saturation (%) will be measured before and after intervention.

Doctor student

Clinical trial, randomized, double-blind and controlled

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

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

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

Placebo Oral Capsule

Clinical Hospital Centre

Silymarin in NAFLD

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

Transient elastography detected by FibroScan®, Echosense, France

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.

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.)

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

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

Goran Hauser

Goran Hauser, Principal investigator

University Hospital Rijeka

University of Rijeka, Medical Faculty

Belupo

University of Rijeka, Faculty of Health studies

Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 6cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.

Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 12cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.

Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 30c, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.

Diet (1600 cal/day) + aerobic exercise (30 min daily) + placebo (87°alcohol), 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.

Dyslipidemia

Menopause

Obesity

Carduus marianus 6cH

Carduus marianus 12cH

Carduus marianus 30cH

Placebo

Exercise

Diet

Hospital Nacional Homeopático

Dose-response Study of Carduus Marianus in Centesimal Scale for Dyslipidemia in Climacteric Overweighed or Obese Women.

Dose-response Study of the Efficacy and Safety of Carduus Marianus in Centesimal Scale for Dyslipidemia in Overweighed or Obese Women in Peri- and Postmenopause: a Randomized Controlled Trial

Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.

Emma del Carmen Macías-Cortés, PhD

Hospital Nacional Homeopático, Mexico

Laboratorio Similia, México

Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)

Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)

Non-alcoholic Fatty Liver Disease

Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)

nutraceutical mixture

Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture

placebo

IRCCS Neuromed

Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

hematic levels of direct and indirect bilirubin

C Reactive Protein (CRP), interleukin (IL)-6, IL-1β, IL-8, IL-10, Receptor for Advanced Glycation End Products (RAGE), Advanced Glycation End Products (AGE), insulin-like growth factor-1 (IGF-1)

Factor VII, fibrinogen, thrombin generation with and without thrombomodulin, antithrombin (AT), tissue-type Plasminogen Activator (t-PA), Plasminogen Activator Inhibitor-1(PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI) and activated TAFI (TAFIa), plasmin-antiplasmin complex, plasma fibrinolytic capacity

glycemia, triglycerides, HDL cholesterol, insulin e insulin-resistance (HOMA-IR homeostasis model assessment-estimated insulin resistance), adiponectin

total cytokeratin-18 (M65 antigene), M30 and M65/M65ED, soluble fas and soluble fas ligand

silymarin/obésité

Effect of Silymarin in Patients With Non-alcoholic Fatty Liver Disease

Silymarin in NAFLD

Dose-response Study of Carduus Marianus in Centesimal Scale for Dyslipidemia in Climacteric Overweighed or Obese Women.

Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

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