Evaluation of effect of flaxseed oil on the non invasive liver marker's in patients with nonalcoholic fatty liver disease and comparison with placebo

Phase 3

Recruiting

Conditions: on-alcoholic fatty liver disease.
Other specified inflammatory liver diseases
K76.0

Registration Number: IRCT20220521054947N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patient satisfaction
AST and ALT level at least 1/5 times normal with ultrasound confirmation of fatty liver
Age: 15 to 60

Exclusion Criteria

Consumption or history of alcohol consumption
Positive serology of viral hepatitis (C, B)
ANA or AMA, alpha 1 antitrypsin positive test, low serum ceruloplasin level or high level of ASMA and LKM14 antibodies
Ferritin above 450 or 45% IRON / TIBC> 5
The patient develops an acute or chronic illness before or during the intervention that interferes with LFT (liver function tests)
The patient take a drug before or during the intervention that has the potential to interfere with LFT
Age less than 15 years and more than 60 years
Pregnancy
Taking herbal medicine

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AST level changes. Timepoint: AST level measurement at baseline and at week 8. Method of measurement: blood sample.;ALT level changes. Timepoint: ALT level measurement at baseline and at week 8. Method of measurement: blood sample.;ALP level changes. Timepoint: ALP level measurement at baseline and at week 8. Method of measurement: blood sample.;Bilirubin total and direct level changes. Timepoint: Bilirubin total and direct level measurement at baseline and at week 8. Method of measurement: blood sample.

Secondary Outcome Measures

Name	Time	Method
Fasting Blood Sugar. Timepoint: at baseline and at week 8. Method of measurement: blood sample.;Weight. Timepoint: at baseline and at week 8. Method of measurement: Weighing scale.;Height. Timepoint: at baseline and at week 8. Method of measurement: Meter.;High-density lipoprotein (HDL). Timepoint: at baseline and at week 8. Method of measurement: Blood sample.;Low-density lipoprotein (LDL). Timepoint: at baseline and at week 8. Method of measurement: Blood sample.;Cholesterol. Timepoint: at baseline and at week 8. Method of measurement: Blood sample.;Triglyceride. Timepoint: at baseline and at week 8. Method of measurement: Blood sample.;Body mass index (BMI). Timepoint: at baseline and at week 8. Method of measurement: Body weight (kg) divided by the square of the body height(m).