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IRCT20190701044062N3 IRCT 2020-09-16 Tabriz University of Medical Sciences comparison the teraputic effect of pioglitazone and carnitine to metformin and carnitine in patients with non alcoholic fatty liver disease comparison the teraputic effect of pioglitazone and carnitine to metformin and carnitine in patients with non alcoholic fatty liver disease 2019-10-22 anticipated 80 Complete https://irct.ir/trial/42845 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Given the fact that the sample size is the same in both groups, we use the Excel software to randomise. Patients will be randomly divided into two groups of carnitine and pioglitazone and carnitine and metformin. 3 non alcoholic fatty liver disease (NAFLD). Intervention 1: Intervention group: For this group of patients, 1000 mg of carnitine and 30 mg of pioglitazone will be prescribed daily for 6 months. Drugs, especially carnitine, are available at different times at different brands due to the embargo conditions. No specific brand is used and only generic drugs are used. We do not have special equipment. Carnitine with 2 tablets of 500 mg in the morning and evening and pioglitazone with a dose of 30 mg tablets daily is given at noon. Patients are followed every three months and the side effects and intolerance of the drug are checked and in the absence of problems and in case of correct and complete use of the prescribed drug, the second 3-month period is prescribed. Intervention 2: Intervention group: For this group of patients, 1000 mg of carnitine and 500 mg of metformin will be prescribed daily for 6 months. Drugs, especially carnitine, are available at different times at different brands due to the embargo conditions. No specific brand is used and only generic drugs are used. We do not have special equipment. Carnitine with 2 tablets of 500 mg in the morning and evening and metformin with a dose of 500 mg tablets daily is given at noon. Patients are followed every three months and the side effects and intolerance of the drug are checked and in the absence of problems and in case of correct and complete use of the prescribed drug, the second 3-month period is prescribed. 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 All authors are required to publish the consent and no further information is available
public Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 1334 3010 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166618564 +98 41 1334 3010 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 17-50 years old Paitents with non alcoholic fatty liver disease who have been ruled out all known causes of fatty liver disease including alcohol, medications, viral hepatitis, autoimmune hepatitis and metabolic causes such as Wilson and hemochromatosis and etc. 17 years 50 years Both Patients with liver disease such as viral hepatitis, autoimmune hepatitis, Wilson, hemochromatosis, liver cirrhosis, and PBC and PSC Patients who drink alcohol. Patients with renal Failure ( Creatinine > 1.5 mg/dl) Patients with known severe systemic disease and malignancy. Pregnancy or breastfeeding Patients with type 1 diabetes K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: For this group of patients, 1000 mg of carnitine and 30 mg of pioglitazone will be prescribed daily for 6 months. Drugs, especially carnitine, are available at different times at different brands due to the embargo conditions. No specific brand is used and only generic drugs are used. We do not have special equipment. Carnitine with 2 tablets of 500 mg in the morning and evening and pioglitazone with a dose of 30 mg tablets daily is given at noon. Patients are followed every three months and the side effects and intolerance of the drug are checked and in the absence of problems and in case of correct and complete use of the prescribed drug, the second 3-month period is prescribed. Intervention group: For this group of patients, 1000 mg of carnitine and 500 mg of metformin will be prescribed daily for 6 months. Drugs, especially carnitine, are available at different times at different brands due to the embargo conditions. No specific brand is used and only generic drugs are used. We do not have special equipment. Carnitine with 2 tablets of 500 mg in the morning and evening and metformin with a dose of 500 mg tablets daily is given at noon. Patients are followed every three months and the side effects and intolerance of the drug are checked and in the absence of problems and in case of correct and complete use of the prescribed drug, the second 3-month period is prescribed. Liver enzymes levels before and after carnitine and pioglitazone administration. Timepoint: At baseline and 3 months later and 6 months after the intervention. Method of measurement: Laboratory methods. Ultrasound grade determination before and after carnitine and pioglitazone. Timepoint: At baseline and 6 months after intervention. Method of measurement: Perform liver ultrasound. Liver enzymes levels before and after carnitine and metformin. Timepoint: At baseline and 3 months later and 6 months after the intervention. Method of measurement: laboratory methods. Ultrasound grade determination before and after carnitine and metformin. Timepoint: At baseline and 6 months after intervention. Method of measurement: Perform liver ultrasound. Tabriz University of Medical Sciences Approved 2019-06-11 Ethics committee of Tabriz University of Medical Sciences Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St. tabriz East Azarbaijan Iran (Islamic Republic of)