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IRCT20140208016529N3 IRCT 2018-10-24 Esfahan University of Medical Sciences The effect of Sour tea supplementation in nonalcoholic fatty liver disease. The effect of Sour tea supplementation on liver enzymes, total antioxidant capacity, glycemic indicator, lipid profile and sonographic outcomes in patients with nonalcoholic fatty liver disease:A randomized controlled trial. 2018-07-23 anticipated 70 Complete https://irct.ir/trial/34247 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be allocating into intervention or placebo group by permuted block randomization method, Blinding description: Sour tea supplement and placebo will have identical appearance. 3 Nonalcoholic Fatty Liver Disease.. Intervention 1: Intervention group will take 500 mg of sour tea tablets, for 8 weeks. Intervention 2: Control group will take placebo tablets with identical appearance containing starch for 8 weeks. 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 Information.
public Fatemeh Izadi
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8487 Fatemeh.Izadi1993@yahoo.com Esfahan University of Medical Sciences scientific Mohammad hassan entezari
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8487 Entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with the nonalcoholic fatty liver disease confirmed with imaging techniques. Body Mass Index (BMI) of them is greater than 24.9 and lower than 40. 23 years 55 years Both Alcohol consumption Pregnant and lactating women Any known forms of hepatic or metabolic disease except NAFLD, such as hereditary hemochromatosis, Wilson’s disease, cirosis, other metabolic disease history of gastric bypass or intestine surgery Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs Using antioxidant supplements Hormone Therapy Patients with a history of Cushing’s syndrome renal failure Participants with less than 80% are going to be excluded. K75.81 Nonalcoholic steatohepatitis (NASH) Treatment - Drugs Treatment - Drugs Intervention group will take 500 mg of sour tea tablets, for 8 weeks. Control group will take placebo tablets with identical appearance containing starch for 8 weeks. Liver enzymes (ALT, AST). Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Using Microgram/ml - laboratory kit. Lipid profile (TG, HDL, Total cholestrol). Timepoint: The first day of the study and the last day of 8th week. Method of measurement: laboratory kit. Liver steatosis index. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Sonography. Fasting blood sugar. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: laboratory kit. Total antioxidant capacity. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: laboratory kit. Waist to hip ratio. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Non-stretchable tape without any pressure. Body Mass Index (BMI). Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Weight (kilograms) divided by the square of height (meters). Sistolic and diastolic blood pressure. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: By mercury sphygmomanometer. Esfahan University of Medical Sciences Approved 2018-03-04 Ethic Committee of Isfahan University of Medical Sciences Department of Clinica Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)