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IRCT20180404039187N1 IRCT 2018-11-22 Tabriz University of Medical Sciences "Evaluation of the effect of Pioglitazone and Vitamin E in Fatty Liver", "The effect of Metformin and UDCA on Fatty Liver" Study of the efficacy of coadministration of Pioglitazone and Vitamin E compared to coadministration Metformin and Ursodeoxycholic acid (UDCA) on ultrasound scoring and liver enzymes in patients with non-alcoholic fatty liver 2018-12-21 anticipated 158 Complete https://irct.ir/trial/33847 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method and description of each method: simple randomization, block Arrange the accident stages: 1) Determine the volume of each block (Foursquare blocks) 2) Prepare block lists and assign numbers to them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Selection of random numbers between 1 and 6 4) Identification of the Treatment Assignment For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5). 2-3 Fatty liver. Intervention 1: Intervention group 1: Individuals receiving Pioglitazone plus Vitamin E: People in this group will receive Pioglitazone 15 mg and Vitamin E 800 mg (400 mg twice daily, Zahravi factory) on a daily basis for 6 months, as well as all patients at the time of arrival, Three months later, at the end of the study (6 months later), blood samples were taken to determine the level of liver enzymes and ultrasound to determine the grade of fatty liver. Measuring the level of liver enzymes in the "Danesh" lab and doing ultrasound at the "Tabesh" imaging center. Intervention 2: Intervention group 2: Individuals receiving Metformin plus Ursodeoxycholic acid: People in this group will receive Metformin at a dose of 500 mg daily and Ursodeoxy cholic acid at a dose of 300 mg (three times a day, making a So.se Italian factury) on a daily basis for 6 months, as well as all patients at the time of arrival, Three months later, at the end of the study (6 months later), blood samples were taken to determine the level of liver enzymes and ultrasound to determine the grade of fatty liver. Measuring the level of liver enzymes in the "Danesh" lab and doing ultrasound at the "Tabesh" imaging center. 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 There is no more information
public Dr Elnaz Shaseb
Pharmacy faculty of tabriz Medical University, Golgaste St, Azadi Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1449 elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences scientific Dr Elnaz Shaseb
Pharmacy faculty of tabriz Medical University, Golgaste St, Azadi Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 51666414766 +98 41 3334 1449 elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-65 years Patients who have been diagnosed with non-alcoholic fatty liver based on ultrasound evidence and tests People with controlled diabetes (HbA1C below 8%) 18 years 65 years Both People with heart failure (HF) Classes 3 and 4 People with kidney failure (GFR <30) People with liver cirrhosis People with bladder cancer People with Osteoporosis Pregnant and lactating women alcohol consumption People who also use other vitamins containing vitamin E at the same time People receiving warfarin K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group 1: Individuals receiving Pioglitazone plus Vitamin E: People in this group will receive Pioglitazone 15 mg and Vitamin E 800 mg (400 mg twice daily, Zahravi factory) on a daily basis for 6 months, as well as all patients at the time of arrival, Three months later, at the end of the study (6 months later), blood samples were taken to determine the level of liver enzymes and ultrasound to determine the grade of fatty liver. Measuring the level of liver enzymes in the "Danesh" lab and doing ultrasound at the "Tabesh" imaging center Intervention group 2: Individuals receiving Metformin plus Ursodeoxycholic acid: People in this group will receive Metformin at a dose of 500 mg daily and Ursodeoxy cholic acid at a dose of 300 mg (three times a day, making a So.se Italian factury) on a daily basis for 6 months, as well as all patients at the time of arrival, Three months later, at the end of the study (6 months later), blood samples were taken to determine the level of liver enzymes and ultrasound to determine the grade of fatty liver. Measuring the level of liver enzymes in the "Danesh" lab and doing ultrasound at the "Tabesh" imaging center Grade ultrasound. Timepoint: At the beginning of the study, 3 months and 6 months later. Method of measurement: Sonography. Liver Enzymes(AST , ALT). Timepoint: At the beginning of the study, 3 months and 6 months later. Method of measurement: Blood test. Lipid profile. Timepoint: At the beginning of the study, 3 and 6 months later. Method of measurement: Blood test. Tabriz University of Medical Sciences Approved 2018-08-27 Ethics Committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)