Effect of Propolis extract on non-alcoholic fatty liver disease

Effect of Propolis extract on hepatic steatosis and fibrosis status in patients with non-alcoholic fatty liver disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180824040857N1

Enrollment

Registered

2018-10-24

Start date

2018-08-01

Completion date

Unknown

Last updated

2020-10-06

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

Conditions

Non- alcoholic fatty liver disease (NAFLD). Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Propolis extract at a dose of 500 mg per day for four consecutive months. Intervention 2: Control group:Placebo at a dose of 500 mg per day for four consecutive mon

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Having evidence of fibrosis and steatosis on liver elastography The absence of alcohol consumption Having no secondary causes of hepatic steatosis such as hepatitis C virus, autoimmune hepatitis, haemochromatosis, hypopituitarism, hypothyroidism, Wilson’s disease, and regular use of hepatotoxic drugs (e.g., amiodarone, tamoxifen, valproate, methotrexate) or corticosteroids.

Exclusion criteria

Exclusion criteria: Pregnancy Lactation Having weight management program

Design outcomes

Primary

Measure	Time frame
Hepatic steatosis. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Two-dimensional shear wave elastography (2-D SWE).;Hepatic fibrosis. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Two-dimensional shear wave elastography (2-D SWE).	—

Secondary

Measure	Time frame
Aspartate aminotransferase (AST). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Total cholesterol. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;LDL. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;HDL. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;TG. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Fasting blood sugar (FBS). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Alanine aminotransferase (ALT). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).	—

Measure

Time frame

Aspartate aminotransferase (AST). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Total cholesterol. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;LDL. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;HDL. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;TG. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Fasting blood sugar (FBS). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Alanine aminotransferase (ALT). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohsen Nematy

Mashhad University of Medical Sciences

NematyM@mums.ac.ir+98 51 3882 7033

Outcome results

None listed

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