Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis

Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Rosuvastatin Versus Coenzyme Q10 on Nonalcoholic Steatohepatitis

This study will be a randomized, controlled, parallel study that aims to evaluate the efficacy and safety of Rosuvastatin versus Coenzyme Q10 on nonalcoholic steatohepatitis patients.

• This study will be a randomized, controlled, parallel study.
• It will be conducted on 46 patients diagnosed with NASH
• The patients will be randomized into two groups:

Group 1(n=23): patients will receive Rosuvastatin 20mg/day orally

Group 2(n=23): patients will receive Coenzyme Q10 100 mg/day orally

The patients will be selected from community awareness campaigns about NASH in Alexandria , Egypt . Written informed consent will be obtained from all patients. This study will be approved by the Research Ethics Committee of Tanta University and Alexandria university.

The study duration will be 3 months.

Inclusion Criteria:

• Age: ≥ 18 years.
• Gender: Both male and female patients will be included.
• Patients have established diagnosis of NASH (based on liver ultrasonography).

Exclusion Criteria:

• Young ages <18 years
• Secondary causes of hepatic fat accumulation such as Significant alcohol consumption as defined by an average daily consumption of alcohol greater than 30 g/day in men and greater than 20 g/day in women or Long-term use of a steatogenic medication (e.g., non-Steroidal anti-inflammatory drugs (NSAIDs) amiodarone, methotrexate, tamoxifen, corticosteroids)
• Patients with a known history of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction.
• Patients with inflammatory diseases.
• Subjects using any other lipid-lowering agents, or any supplements known to have antioxidant activity and omega-3 supplementation for at least 3 months before participation in the trial
• Current Pregnancy
• Breastfeeding
• Females On Oral Contraceptive pills
• Patients with renal impairment
• Patients with heart failure
• Patients with cancer or with a history of cancer treatment
• Any contraindications to coenzyme Q 10 Or statins like hypersensitivity to anyone
• Patients with predisposing risk factors for myopathy/rhabdomyolysis.