]>
IRCT20190701044062N8 IRCT 2021-09-26 Tabriz University of Medical Sciences comparison the therapeutic effect of pioglitazone and carnitine to pioglitazone and vitamin E in patients with non alcoholic fatty liver disease comparison the therapeutic effect of pioglitazone and carnitine to pioglitazone and vitamin E in patients with non alcoholic fatty liver disease 2019-10-23 anticipated 80 Complete https://irct.ir/trial/45257 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using GraphPad software. So that the random sequence for the two groups will be determined by a person who has no role in other parts of the research using this software. Patients will then be assigned to each of the groups of pioglitazone and carnitine or pioglitazone and vitamin E depending on the clinic visit. Our colleague will place the group plan in a sealed envelope and present it to the patient to take to the researcher proving the drugs and receive the drug group. The sequence will remain with the researcher until the end of the study. The output of the software is A and B and people will be randomly assigned to each of groups A and B. The labels of groups A and B will be affixed to the intervention packages or placebo by a person who has no role in other parts of the research, and at the end of the study, after statistical analysis, the content of groups A and B will be determined. 3 Non alcoholic fatty liver disease. Intervention 1: Intervention group: pioglitazone 30mg daily and carnitine 1000mg daily for 6 months. Intervention 2: Control group: pioglitazone 30mg daily and vitamin E 800mg daily for 6 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 All authors are required to publish the consent and no further information is available
public Manouchehr Khoshbaten
Golgasht Ave
Tabriz Iran (Islamic Republic of) 5166618564 +98 41 3336 0840 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Golgasht Ave
Tabriz Iran (Islamic Republic of) 5166618564 0984133360840 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with non alcoholic fatty liver disease 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: pioglitazone 30mg daily and carnitine 1000mg daily for 6 months Control group: pioglitazone 30mg daily and vitamin E 800mg daily for 6 months Liver enzymes levels. Timepoint: At baseline, 3 and 6 months after the intervention. Method of measurement: Laboratory methods. Ultrasound grade. Timepoint: At baseline and 6 months after intervention. Method of measurement: Perform liver ultrasound. . Timepoint: . Method of measurement: . Tabriz University of Medical Sciences Approved 2019-10-01 Ethics committee of Tabriz University of Medical Sciences Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)