]>
IRCT20121105011375N5 IRCT 2018-05-10 Shiraz University of Medical Sciences Effect of Silymarin, Metformin, and life style in non-alcoholic fatty liver disease Effect of silymarin, metformin, and life style in patients with non-alcoholic fatty liver disease in Marvdasht Hospital 2018-05-22 anticipated 90 Complete https://irct.ir/trial/30794 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using a randomization table based on the registration number of the patients. Study pills will be allocated in separate packs blinded and labeled using a four-digit code, Blinding description: Apart from the outcome assessor, patients, care provider, investigator, and members collecting and analyzing data will be blinded to the intervention allocation. N/A Non-alcoholic fatty liver. Intervention 1: Intervention group: lifestyle modification and Metformin 500 mg/day for 3 months. Intervention 2: Intervention group: lifestyle modification and Silymarin 140 mg/day for 3 months. Intervention 3: Control group: lifestyle modification and placebo for 3 months. Yes - There is a plan to make this available What will be shared: The patients will be randomly divided into three study groups; group A subjects will be treated with only lifestyle modification and placebo. Group B subjects will be administered with lifestyle modification and Metformin 500 mg/day. Group C subjects will be received lifestyle modification and Silymarin 140 mg/day. The primary outcomes are biomarker changes including AST, ALT, FBS, TG, CHOL, LDL, and HDL at initial and 3 months after intervention. In addition, we will be considered BMI, and waist circumference as secondary outcomes. All data related to the patients will be shared after deidentifing the patients. When: starting 1 month after publication To whom: This only available for people working in academic institutions Conditions: All statistical analysis are allowed in line with the objectives of the study. Application terms for access to data including: People working in academic institutions who have registered a protocol liked our study. People are committed to data protection. Where to obtain: Vahid Mohammad Karimi, Shiraz Nemazee Hospital, Email: mohamadkv@sums.ac.ir How to obtain: Through automation correspondence or email Comments:
public Maedeh Pourfarmanbar
Shiraz Medical School, Zand Ave.
Shiraz Iran (Islamic Republic of) 71348-45794 +98 71 3230 5645 taranehh99@yahoo.com Shiraz University of Medical Sciences scientific Vahid Mohammad Karimi
Department of Internal Medicine, Nemazee Hospital, Zand Ave
Shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3647 4332 mohamadkv@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with NAFLD confirmed by performing liver sonography Increased levels of liver enzymes AST and ALT 18 years 60 years Both History of alcohol consumption Diabetes Chronic liver disease Use of drugs such as statin, fibrate K75.81 Nonalcoholic steatohepatitis (NASH) Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: lifestyle modification and Metformin 500 mg/day for 3 months Intervention group: lifestyle modification and Silymarin 140 mg/day for 3 months Control group: lifestyle modification and placebo for 3 months Liver function test. Timepoint: Before intervention, 3 months after intervention. Method of measurement: ELISA. Body Mass Index. Timepoint: Before intervention, 3 months after intervention. Method of measurement: By BMI Formula. Shiraz University of Medical Sciences Approved 2018-04-16 Ethics Committee of Shiraz University of Medical Sciences Building of Shiraz University of Medical Sciences, Zand Ave Shiraz Fars Iran (Islamic Republic of)