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

Tanta University46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nonalcoholic Steatohepatitis

Interventions

Rosuvastatin 20 Mg Oral TabletDRUG

Rosuvastatin 20 mg will be administered orally once daily for 3 Months

Coenzyme Q10 100 MG Oral CapsuleDRUG

Coenzyme Q10 100 mg will be administered orally once daily for 3 Months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.