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IRCT20210514051287N1 IRCT 2022-03-04 Qazvin University of Medical Sciences Comparison of metformin and livergol in patients with non-alcoholic fatty liver disease Comparison of the effect of metformin and livergol in liver enzymes in patients with non-alcoholic fatty liver 2022-04-09 anticipated 80 Complete https://irct.ir/trial/61021 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Statistical analysis of data will be performed using SPSS statistical software version 20. To describe the data from the mean and standard deviation and absolute and relative frequency and for the analytical part after the normality check of the data using Kolmogorov-Smirnov test from independent two-sample t-test, ANOVA, and in case Relevant parametric bread tests will be used for data abnormality, Randomization description: Randomization of patients is done by balanced block randomization method with blocks with size of 4. For allocation concealment group names will be placed in envelopes. the envelopes will be numbered from 1 to 80 and will be put in the box, respectively. The researcher who makes the random assignment will be aware of the contents of the envelopes. The content of the envelopes indicates the study groups. After ensuring that sample enters the research and obtains written consent, The first envelope is elected in order of numbers and patient is appointed in one of the study groups according to the contents of the envelope, Blinding description: The present study is a single-blind study in which the two drugs studied in this study in terms of all physical characteristics, including; Shape, color, taste, size and packaging are simulated to enable blinding at the participant level. 3 Non-alcoholic fatty liver. Intervention 1: First, the studied variables are evaluated before the intervention, then this group will receive metformin (N,N-dimethylbiguanide) with the chemical composition of C4H11N5 and a dose of 500 mg produced by Dr. Abidi Pharmaceutical Company orally. As they will be explained in the first visit, they should take half a tablet (250 mg) in breakfast and lunch for the first 2 weeks, and after two weeks, they will return again to order the use of one metformin tablet (500 mg) to receive .After two months of treatment, they will come again to check for the desired variables. Intervention 2: First, the studied variables are evaluated before the start of the intervention, then this group will receive Livergol drug (dried extract, sage extract) at a dose of 140 mg produced orally by Dr. Abidi Pharmaceutical Company. In the first visit, this group will be instructed to take one tablet (140 mg) daily for two months and to refer again after two months to check the desired variables. 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 Tahereh Mahdavi
Qazvin, Minoodar, taavon Square, Provincial Educational and Medical Center
Qazvin Iran (Islamic Republic of) 3464186699 +98 28 3379 0611 dr.amirrezakhazzaei@gmail.com Qazvin University of Medical Sciences scientific Tahereh Mahdavi
Qazvin, Minoodar, taavon Square, Provincial Educational and Medical Center
Qazvin Iran (Islamic Republic of) 3464186699 +98 28 3379 0611 dr.amirrezakhazzaei@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Non-alcoholic fatty liver based on ultrasound increase liver enzymes above normal 18 years no limit Both People with suspected fatty liver disease according to history in terms of alcohol consumption, the presence of other concomitant diseases such as hepatitis B, C, insulin use Pregnancy Taking effective LFT drugs K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs First, the studied variables are evaluated before the intervention, then this group will receive metformin (N,N-dimethylbiguanide) with the chemical composition of C4H11N5 and a dose of 500 mg produced by Dr. Abidi Pharmaceutical Company orally. As they will be explained in the first visit, they should take half a tablet (250 mg) in breakfast and lunch for the first 2 weeks, and after two weeks, they will return again to order the use of one metformin tablet (500 mg) to receive .After two months of treatment, they will come again to check for the desired variables. First, the studied variables are evaluated before the start of the intervention, then this group will receive Livergol drug (dried extract, sage extract) at a dose of 140 mg produced orally by Dr. Abidi Pharmaceutical Company. In the first visit, this group will be instructed to take one tablet (140 mg) daily for two months and to refer again after two months to check the desired variables. TG. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on turbidometric tests. Ch. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on turbidometric tests. LDL. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on turbidometric tests. HDL. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on turbidometric tests. BS. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on turbidometric tests. SGPT. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on turbidometric tests. SGOT. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on turbidometric tests. BMI. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Based on measurement and calculation. Degree of liver steatosis. Timepoint: Before intervention and 2 months after intervention. Method of measurement: According to the pathology report. Patient recovery rate. Timepoint: Two months later the intervention. Method of measurement: Based on examination and tests. Side effects of treatment. Timepoint: Two months later the intervention. Method of measurement: Based on examination and tests. Qazvin University of Medical Sciences Approved 2021-05-05 Ethics Committee of Qazvin University of Medical Sciences Shahid Beheshti St., Clinical Research Development Center Qazvin Qazvin Iran (Islamic Republic of)