effect of pomegranate peel extract on non-alcoholic fatty liver disease

Phase 3

Recruiting

Conditions: onalcoholic fatty liver disease.
Fatty (change of) liver, not elsewhere classified
K76.0

Registration Number: IRCT20091114002709N58

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

Alanine aminotransferase (ALT) greater than 20 IU/L for women and greater than 30 IU/L for men.
Evidence of fatty liver in ultrasonography with a score of 1 or 2.
Being volunteer or Wishing to attend.
age: 30 to 60 years.
BMI: 25Kg/m2 to 35Kg/m2.

Exclusion Criteria

Other acute or chronic hepatic disorders
cardiovascular disease, renal disease, infectious disease, diabetes, cancer.
hemorrhoid or chronic constipation.
intensive weight loss or weight gain during 3 months prior to intervention.
Any use of antioxidant supplements during 1 month prior to intervention.
Use of hepatotoxic medications during last month.
Use of lipid lowering medications or insulin-sensitizing medications.
Problem in blood coagulation.
Dysmenorrhea or excessive bleeding during menses.
History of benign tumours.
Consumption of alcohol, addictive drugs and smoking.
The patient's unwillingness to continue cooperation.
pregnancy.
lactation.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alanine aminotransferase (ALT). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.;Aspartate aminotransferase (AST). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.

Secondary Outcome Measures

Name	Time	Method
High density lipoprotein cholesterol (HDL-C). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.;Low density lipoprotein cholesterol (LDL-C). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.;Alkaline phosphatase (ALP). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.;Total cholesterol (TC). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.;Triglyceride (TG). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.;High sensitive reactive protein (hs-CRP). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit.