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IRCT20100524004010N25 IRCT 2018-07-24 Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research The effect of Nigella sativa on Non-Alcoholic Fatty Liver Disease(NAFLD) The effect of Nigella sativa consumption on lipid profile, liver enzymes, inflammatory factors and hepatic steatosis in patients with Non-Alcoholic Fatty Liver Disease(NAFLD) 2017-02-28 anticipated 50 Complete https://irct.ir/trial/4197 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to receive Nigella sativa or placebo, Blinding description: For randomization process, simple randomization method is used by random number table. At the beginning of the study, in order to blind the researchers to group assignment, the cans containing the capsules are coded by another person instead of the researcher to A and B as intervention and control groups. N/A Non alcoholic fatty liver disease. Intervention 1: Intervention group: 2 gr per day nigella sativa daily for 3 months. Intervention 2: Placebo group: 2 gr per day starch daily for 3 months. 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 We have not yet decided for it.
public Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Hafezi Ave
Tehran Iran (Islamic Republic of) 123456 +98 21 2235 7483 a_HEKMAT2000@YAHOO.COM Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research scientific Azita Hekmatdoost
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
Tehran Iran (Islamic Republic of) 123456 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research Iran (Islamic Republic of) 18 years old and older Evidence of nonalcoholic steatohepatitis in Fibroscan (Controlled Attenuation Parameter (CAP) score> 263) absence of pregnancy and lactation 18 years no limit Both Unwillingness to continue study for any reason. (K75.8) Other specified inflammatory liver diseases Treatment - Other Treatment - Other Intervention group: 2 gr per day nigella sativa daily for 3 months Placebo group: 2 gr per day starch daily for 3 months HOMA. Timepoint: Begining and end of the study. Method of measurement: Calculation. TNF-α. Timepoint: Begining and end of the study. Method of measurement: Elisa. IL-6. Timepoint: Begining and end of the study. Method of measurement: Elisa. Hepatic Steatosis. Timepoint: Begining and end of the study. Method of measurement: Ultrasound. LDL-C. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit. HDL-C. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit. TG. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit. Total Cholesterol. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit. Serum Insulin. Timepoint: Begining and end of the study. Method of measurement: Radioimmunoassay. FBS. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kits. AST. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kits. ALT. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit. Total energy intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Carbohydrate intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Protein intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total fat intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. SFA intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. PUFA intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. MUFA intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Fiber intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total energy intake. Timepoint: Begining and end of the study. Method of measurement: Questionnaire. Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research Approved 2017-02-19 National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci West Arghavan, Sanaat Square, Farahzadi Boulvard, Shahrake Gharb Tehran Tehran Iran (Islamic Republic of)