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IRCT20180103038199N16 IRCT 2023-05-01 Mashhad University of Medical Sciences Evaluation of the effectiveness of ellagic acid on patients with non-alcoholic fatty liver disease Evaluation of the effectiveness of ellagic acid on liver steatosis in patients with non-alcoholic fatty liver disease 2023-04-21 anticipated 60 Complete https://irct.ir/trial/69690 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 15 blocks according to the sample size of 60. Then random numbers between 1 and 15 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 2 Patients with non-alcoholic fatty liver disease. Intervention 1: Intervention group: receiving Ellagic acid capsules 200 mg once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy. Intervention 2: Control group: receiving placebo capsules of the same shape and size once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy. 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 It is not yet known if there will be a plan to make this available

public Vahid Reza Askari

Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad

Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv941@mums.ac.ir Mashhad University of Medical Sciences scientific Vahid Reza Askari

Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad

Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv941@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 30-65 years old Body composition index between 25-35 Diagnosis of liver steatosis by two-dimensional elastography (grade 2 and above) Fatty liver patients with grade F0 and F1 30 years 65 years Both Viral hepatitis (especially hepatitis C) Alcoholic fatty liver or consumption of alcohol Diseases such as Wilson's disease, hemochromatosis, celiac disease, cirrhosis, biliary obstruction and primary biliary cirrhosis Special nutritional conditions such as starvation, fasting, and intravenous feeding Smoker Breastfeeding or pregnancy History of hypersensitivity to pomegranate and its products Diabetes Taking any kind of herbal supplements Fatty liver patients with grade F2, F3, F4 K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: receiving Ellagic acid capsules 200 mg once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy. Control group: receiving placebo capsules of the same shape and size once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy. Hepatic steatosis. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Elastography. Hepatic fibrosis. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Elastography. Changes in lipid profile. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Fasting blood sugar. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Fasting insulin. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Uric acid. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Serum Creatinine. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Changes in Interleukin-6 levels. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Changes in hs-CRP serum level. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Changes in ALT level. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Changes in AST level. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Changes in ALP level. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Changes in GGT level. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Laboratory kit. Physical activity score. Timepoint: At the beginning of the study and after 1 and 2 months of treatment. Method of measurement: IPAQ questionnaire. Body weight. Timepoint: At the beginning of the study and after 1 and 2 months of treatment. Method of measurement: A scale with an accuracy of 100 grams. Body Composition. Timepoint: At the beginning of the study and after 1 and 2 months of treatment. Method of measurement: BIA. Mashhad University of Medical Sciences Approved 2023-03-07 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)