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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180103038199N16

Enrollment

Registered

2023-05-01

Start date

2023-04-21

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

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 ene

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Hepatic steatosis. Timepoint: At the beginning of the study and after 2 months of treatment. Method of measurement: Elastography.	—

Secondary

Measure	Time frame
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 mon	—

Measure

Time frame

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 mon

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Reza Askari

Mashhad University of Medical Sciences

askariv941@mums.ac.ir+98 51 3800 2264

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026