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IRCT2015062115587N9 IRCT 2016-02-18 Vice –Chancellor of Shiraz University of Medical Sciences Effect of cinnamon on liver disease Evaluation of the therapeutic effect of oral administration of cinnamon on Non-alcoholic steatohepatitis (NASH) 2015-08-23 anticipated 60 Complete https://irct.ir/trial/14814 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients were divided into two 30 member groups by Permutated block randomization. 2-3 Non-alcoholic steatohepatitis. Intervention 1: Intervention group: Patients will receive 250 mg cinnamon capsules, prepared in Shiraz University of Medical Sciences, faculty of pharmacy, 4 times a day for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly. Control group: Will receive 400 mg Vitamin E capsule, once daily for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly. Intervention 2: Control group: Patients will receive 400 mg Osve Vitamin E capsule, once daily for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly.
public Maryam Moeeni
Namazi Hospital, Namazi Square, Shiraz
Shiraz Iran (Islamic Republic of) +98 71 3612 5518 moeenim@sums.ac.ir Gastroenterohepatology Research Center of Shiraz scientific Maryam Moeeni
Namazi Hospital, Namazi Square, Shiraz
Shiraz Iran (Islamic Republic of) +98 71 3612 5518 moeenim@sums.ac.ir Gastroenterohepatology Research Center of Shiraz Iran (Islamic Republic of) Inclusion criteria of the study: ALT level higher than 65U/L; Diagnosed fatty liver in ultrasonography; No alcohol and drug abuse; No history of chemotherapy in the past years; No history of other chronic liver diseases such as hepatitis B and hepatitis C, cirrhosis, bile diseases, autoimmune diseases, cancer and any genetic disorder that effects liver function such as Wilson’s disease; No history of lipid-lowering drug use; No pregnancy and breast-feeding; No use of vitamin E supplements; No use of drugs that caused fatty liver, like tetracycline, vitamin A, methotrexate, amiodarone, tamoxifen, etc.; No history of use of hepatotoxic drugs in the last 6 months; No long-term use of herbal drugs Exclusion criteria: If the patient indicates hypersensitivity reactions to cinnamon, becomes pregnant or not interested, and also if the level of liver enzymes rises at the end of the forth week due to cinnamon consumption, the patient will be excluded from the study. 18 years 65 years Both K75.8 nonalcoholic steatohepatitis Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive 250 mg cinnamon capsules, prepared in Shiraz University of Medical Sciences, faculty of pharmacy, 4 times a day for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly. Control group: Will receive 400 mg Vitamin E capsule, once daily for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly. Control group: Patients will receive 400 mg Osve Vitamin E capsule, once daily for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly. Reduction in ALT serum level. Timepoint: Before intervention, at the end of the fourth week of intervention, at the end of the eighth week of intervention. Method of measurement: Blood test and laboratory kits. Reduction in AST serum level. Timepoint: Before intervention, at the end of the fourth week of intervention, at the end of the eighth week of intervention. Method of measurement: Blood test and laboratory kits. Lipid profile improvement. Timepoint: Before intervention, at the end of the fourth week of intervention, at the end of the eighth week of intervention. Method of measurement: Blood test and laboratory kits. Vice –Chancellor of Shiraz University of Medical Sciences Approved 2015-05-17 Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Shiraz Iran (Islamic Republic of)