Efficacy of L-carnitine in decrease of liver enzymes and liver fat content in patients with non-alcoholic fatty liver disease

Assessment of the efficacy of L-carnitine in treating patients with non-alcoholic fatty liver disease, including improvement in laboratory parameters and liver fat content

The clinical trial, consisting of a control group, parallel groups, double-blind design, and randomization, is conducted in Phase 3 on 102 patients. Excel's rand function was used for randomization

L-carnitine, which plays a crucial role in lipid metabolism and beta-oxidation, has drawn researchers' attention for nonalcoholic fatty liver disease. In this study, a multicenter, double-blind study firstly, the metabolic profile of participants would be determined and record. Then, participants in the group LC will receive LC at a dose of 1000 mg twice a day for 3 months, and other group receive placebo. Then reevaluate for liver enzymes and hepatic fat status using ultrasound. Finally, these parameters would be assessed and compare between the two groups.

Inclusion criteria: - Age over 15 years - AST, ALT levels above the normal range - Sonographic findings consistent with fatty liver - No history of viral hepatitis or conditions such as hemochromatosis, Wilson’s disease, autoimmune hepatitis, alpha-1 antitrypsin deficiency, or chronic liver disease Exclusion criteria: - Development of evidence of chronic liver disease - Significant alcohol consumption - History of allergy to medication - Pregnant or breastfeeding women

Patients diagnosed with non-alcoholic fatty liver disease by adult gastroenterologists and hepatologists are randomly assigned to two groups: one receiving L-carnitine supplements, at a dose of 1000 milligrams twice daily for three months, and the other receiving a placebo with a similar administration schedule.

Reduction in serum liver enzymes; decrease in hepatic fat levels on ultrasound.

The randomization process will be such that, based on a predetermined list including the patient's row number and the type of intervention (drug or placebo) randomly assigned (Excel's rand function was used for randomization), eligible individuals will be sequentially enrolled into either the drug or placebo group.

In this study, after obtaining informed consent from the patient regarding participation, the type of intervention (drug or placebo) is not disclosed. The visiting physician, guided by a pre-randomized list, determines whether the patient should receive the drug or placebo. However, other colleagues receiving intervention results for evaluation and analysis will remain unaware of which group the patient belonged to.