Milk thistle (Silymarin marianum) extract supplementation on nonalcoholic fatty liver disease
Phase 3
Recruiting
- Conditions
- Morbid obesity and non alchoholic liver diseade.Overweight and obesity
- Registration Number
- IRCT20210817052218N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
patients aged between 18 and 65 years
morbidly-obese patients candidates for bariatric surgery , BMI above 40 kg/m2
Diagnosis of NAFLD in liver sonography (grades II and III steatosis) with increased levels of liver enzymes aspartate transaminase (AST) and alanine transaminase (ALT) (above 20 mg/dl for women and 30 mg/dl for men)
Exclusion Criteria
history of alcohol consumption
diabetes mellitus
chronic liver disease
use of drugs such as statin, fibrate, non-steroidal anti-inflammatory drugs (NSAIDs),
positive results for tests of autoimmune hepatitis and virus markers (hepatitis B surface antigen, hepatitis C virus antibody)
unwilling to participate in study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Aspartate aminotransferase/alanine aminotransferase ratio. Timepoint: before and after two months of treatment. Method of measurement: Blood sample.;BMI (body mass index). Timepoint: before and after two months of treatment. Method of measurement: scale.;Non alchoholic fatty liver disease. Timepoint: before and after two months of treatment. Method of measurement: Sonography.;Liver fibrosis. Timepoint: before and after two months of treatment. Method of measurement: Fibroscan Metavir.
- Secondary Outcome Measures
Name Time Method