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IRCT20190819044565N2 IRCT 2019-12-24 Oroumia University of Medical Sciences The evaluation of the effect of brewed chicory leaf consumption in patients with non-alcoholic fatty liver disease The evaluation of the effect of brewed chicory leaf consumption on liver steatosis, enzymes, metabolic syndrome components, oxidative stress markers, C-reactive protein in patients with non-alcoholic fatty liver disease 2019-10-23 anticipated 60 Complete https://irct.ir/trial/42751 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Stratified Block Randomization statistical software, Blinding description: The data analyzer will encode the names of the individuals and the clinical caregiver, researcher, outcome assessor, and data analyzer will be kept blind to the assigned study groups and the chicory leaf will be distributed by the person not present in the study. 3 non-alcoholic fatty liver disease. Intervention 1: Intervention group: Apart from routine treatment by the gastroenterologist, they will receive 15 grams of chicory leaf daily for 12 weeks and And they will use dietary guidelines for Iranians to keep their diet uniform. Intervention 2: Control group: They will receive only routine gastrointestinal specialty treatment and will use dietary guidelines for Iranians to maintain a uniform diet. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Samira Faraji
Urmia University of Medical Sciences, Serow highway, Nazloo, Urmia, Iran
Urmia Iran (Islamic Republic of) 5714783734 +98 41 3343 6241 FarajiSamira2019@yahoo.com Oroumia University of Medical Sciences scientific Dr. Mohammad Alizadeh
Department of Nutrition, Urmia University of Medical Sciences, Serow highway, Nazloo, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3275 2375 alizadeh.m@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Grade 2 and 3 non-alcoholic fatty liver disease through observation of steatosis in ultrasound Older than 18 years Interested in attending in study that filled out an informed consent form 18 years no limit Both Mental, emotional, cognitive and mental disorders Grade 1 non-alcoholic fatty liver disease alcohol consumption Hepatitis B, Hepatitis C, Autoimmune Hepatitis, Liver Cancer, Cholestatic Liver Disease Rheumatoid arthritis and other acute inflammatory diseases Taking non-steroidal anti-inflammatory drugs, cholesterol-lowering drugs to control blood pressure such as statins, phenytoin, karmabazepine and barbiturates such as phenobarbital Alpha-1 antitrypsin deficiency Pancreatitis Heart failure Bone diseases Coeliac disease Supplement of Vitamin, Antioxidant, Fiber and Omega 3 Do not regularly use of brewed chicory leaf during the study Use of anticoagulants Hepatotoxic drugs Hereditary hemochromatosis Wilson's disease Pregnant women Lactating women Use of contraceptives drugs liver transplant kidney diseases Changes in the level of physical activity during the study Diabetes Mellitus Hypothyroidism K76 Other diseases of liver Treatment - Other N/A Intervention group: Apart from routine treatment by the gastroenterologist, they will receive 15 grams of chicory leaf daily for 12 weeks and And they will use dietary guidelines for Iranians to keep their diet uniform. Control group: They will receive only routine gastrointestinal specialty treatment and will use dietary guidelines for Iranians to maintain a uniform diet. Hepatic steatosis. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: ultrasound. Alanine transaminase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Aspartate transaminase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Gamma-glutamyl transferase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Alkaline phosphatase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. High-density lipoprotein. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Low-density lipoprotein. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Triglyceride. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Cholesterol. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. FBS. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Total antioxidant capacity. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Superoxide dismutase. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Hs-CRP. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Insulin. Timepoint: Beginning and End of Study (Week 12). Method of measurement: ELISA method, BT1500 machine. HOMA-IR. Timepoint: Beginning and End of Study (Week 12). Method of measurement: Formula. QUICKI. Timepoint: Beginning and End of Study (Week 12). Method of measurement: Formula. Albumin. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Creatinine. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Bilirubin total. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. CBC. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Using the cell counter. Calcium. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Phosphorus. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine. Sodium. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: blood sample. Potassium. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: blood sample. Mean systolic and diastolic blood pressure. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: blood pressure monitor. Oroumia University of Medical Sciences Approved 2019-10-20 Ethics committee of Urmia University of Medical Sciences Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)