Non-alcoholic fatty liver disease. Other specified diseases of liver
Conditions
Interventions
Intervention 1: Intervention group: Livermed (700 mg of purified silymarin with at least 7.5% total silybin A and B, along with glycerol, PEG, and gelatin) 3 times a day for 12 weeks. Intervention 2:
Sponsors
Assistant Professor of Education and Research at Imam Khomeini Hospital Complex
Zardband Pharmaceuticals
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18 to 65 years Confirmed diagnosis of NAFLD grade 2 or 3 by a physician Understanding clinical study conditions and guidelines Patient consent to participate in the study Adherence to a healthy diet and lifestyle (standard treatment) No alcohol consumption There is no other liver disease
Exclusion criteria
Exclusion criteria: Pregnancy, breastfeeding, or planning to become pregnant during the study period History of allergy to products made from thistle or chicory family plants Patients with viral diseases such as hepatitis C, hepatitis B, HIV, cytomegalovirus, Epstein-Barr virus, known cirrhosis, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis Concurrent participation in another clinical trial involving an investigational drug, procedure, or device that interferes with this clinical study or history of participation in other nonalcoholic fatty liver clinical intervention trials Use of drugs associated with NAFLD including amiodarone, tamoxifen, methotrexate, systemic glucocorticoids, anabolic steroids, tetracycline, estrogens in higher doses than oral contraceptives, L-asparaginase, valproate, chloroquine or antiretroviral drugs, probiotics, glutathione, alpha-tocopherol , or non-prescribed alternative medicines (including nutritional supplements, megadose vitamins, herbal products and specialty teas) Patients with a history of bowel surgery, gastrointestinal (bariatric) surgery, or being evaluated for bariatric surgery, extensive small bowel resection, or orthotopic liver transplantation Renal disease, cardiovascular disease: unstable angina, acute coronary syndrome, acute myocardial infarction or arrhythmia, uncontrolled blood pressure, stroke or transient ischemic attack History or other evidence of severe illness or any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study (such as poorly controlled psychiatric illness, HIV, coronary artery disease, or active gastrointestinal conditions that may interfere with medication, active malignancy neoplasm) Abuse of illegal substances Regular or excessive alcohol consumption
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| This study will assess changes in liver fat grade based on ultrasound, alterations in glucose, lipid, and uric acid profiles, HOMA-IR, FIB-4, CBC, CRP, GGT levels, and changes in inflammatory marker IL-6 and oxidative stress MDA. Timepoint: The duration of drug use is 12 weeks. In this study, tests and ultrasound are performed at the beginning and end of 12 weeks. Method of measurement: In this study, the level of factors is done by serum test and diagnosis of liver by ultrasound. | — |
Primary
| Measure | Time frame |
|---|---|
| In this study, the amount and manner of change by measuring liver enzymes in the way the disease state changes is considered as one of the primary outcomes. Timepoint: The duration of drug use is 12 weeks. In this study, tests and ultrasound are performed at the beginning and end of 12 weeks. Method of measurement: In this study, the level of factors is done by serum test and diagnosis of liver by ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactForoogh Alborzi
Tehran University of Medical Sciences
Outcome results
None listed