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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220521054947N1
Enrollment
60
Registered
2022-08-12
Start date
2022-08-16
Completion date
Unknown
Last updated
2022-08-29

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. Other specified inflammatory liver diseases

Interventions

Intervention 1: Intervention group: In the intervention group, flaxseed oil capsules made by Barij Essense Company is prescribed in a dose of 1g 2 times a day for 2 months (one capsule two times a da

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDelaram Omidvar

Mashhad University of Medical Sciences

omidvard971@mums.ac.ir+98 51 3840 0000

Outcome results

None listed

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