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IRCT2017012232109N1 IRCT 2017-03-12 Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences The effect of black cumin on non alcholic fatty liver The clinical trial of evaluation of the effect of black cumin (nigella sativa) extract supplementation on serum levels of some inflammatory markers, liver enzymes, lipid profile ,insulin and fasting plasma glucose in patients with non-alcoholic fatty liver disease 2017-04-24 anticipated 44 Complete https://irct.ir/trial/25099 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Sealed envelope method. 2 Non alcholic fatty liver. Intervention 1: Intervention group: Black Seed Oil, 1000 mg capsule, once a day for 8 weeks. Intervention 2: Control group: paraffin oil, 1000 mg capsule, once a day for 8 weeks.
public Mohammad rashidmayvan
Golestan Ave., Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3333 3050 rashidmayvan.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Majid Mohammadshahi
Golestan St., Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3333 3050 shahi334@gmail.com Ahvaz Jundishapur University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients aged 20 to 60 years diagnosed with nonalcoholic fatty liver by ultrasound, confirmed by a radiologist and a gastroenterologist. Exclusion criteria: pregnancy and lactation; liver transplantation; smoking; alcohol and drug abuse; consuming drugs such as corticosteroids, amiodarone, tamoxifen, methotrexate; receiving total parenteral nutrition; rapid weight loss; diabetes; heart failure; thyroid problems; kidney disease; hereditary hemochromatosis and Wilson disease; have a positive test for hepatitis C, B and autoimmune hepatitis; alpha-1 antitrypsin deficiency. 20 years 60 years Both K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: Black Seed Oil, 1000 mg capsule, once a day for 8 weeks. Control group: paraffin oil, 1000 mg capsule, once a day for 8 weeks Tumor necrosis factor. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA. Interleukin 6. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA. Liver enzymes(aspartate aminotransfrase,alanin aminotransferase,gama glutamil transferase). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits. C reactive protein. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA. Lipid profiles(triglycrid,HDL,LDL and total chollestrol). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits. Insulin. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA. Fast blood sugar. Timepoint: before and 8 weeks after intervention. Method of measurement: Enzymatic chlorometric method. Waist to hip ratio. Timepoint: before and 8 weeks after intervention. Method of measurement: Inelastic tape without putting pressure on the body. Body mass index. Timepoint: before and 8 weeks after intervention. Method of measurement: The ratio of weight in kilograms by the square of height in meters. Systolic and diastolic blood pressure. Timepoint: before and 8 weeks after intervention. Method of measurement: Sphygmomanometer. Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences Approved 2017-01-21 Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave. Ahvaz Iran (Islamic Republic of)