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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Coenzyme Q10; Rosuvastatin Calcium; Ubiquinone

Criteria

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.