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

Tanta University

Status and phase: Not yet enrolling; Phase 3

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: Coenzyme Q10 100 MG Oral Capsule; Drug: Rosuvastatin 20 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05731596

Rosuvastatin vs Co Q10 on NASH

Details and patient eligibility

About

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.

Full description

• 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Group 1 (Rosuvastatin group)

Active Comparator group

Description:

Patients will receive Rosuvastatin 20mg/day orally for 3 months

Treatment:

Drug: Rosuvastatin 20 Mg Oral Tablet

Group 2 (CoQ10 group)

Experimental group

Description:

Patients will receive Coenzyme Q10 100 mg/day orally for 3 months

Treatment:

Drug: Coenzyme Q10 100 MG Oral Capsule