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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: Rosuvastatin 20 Mg Oral Tablet
* Drug: Coenzyme Q10 100 MG Oral Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Rosuvastatin group)<br>Patients will receive Rosuvastatin 20mg/day orally for 3 months | Drug: Rosuvastatin 20 Mg Oral Tablet<br>* Rosuvastatin 20 mg will be administered orally once daily for 3 Months<br>|
| Experimental: Group 2 (CoQ10 group)<br>Patients will receive Coenzyme Q10 100 mg/day orally for 3 months | Drug: Coenzyme Q10 100 MG Oral Capsule<br>* Coenzyme Q10 100 mg will be administered orally once daily for 3 Months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver stiffness measurement (LSM) | LSM will be assessed by Fibro scan | At baseline and 12th week | 
| Change in ultrasound score | Ultrasound score will be assessed by Ultrasonography | At baseline and 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate changes in Alanine aminotransferase (ALT) | Alanine aminotransferase (ALT) in U/L | At baseline and 12th week | 
| Demonstrate changes in Aspartate aminotransferase (AST) | Aspartate aminotransferase (AST) in U/L | At baseline and 12th week | 
| Demonstrate changes in Alkaline phosphatase (ALP) | Alkaline phosphatase (ALP) in U/L | At baseline and 12th week | 
| Demonstrate changes in ɤ-glutamyltranspeptidase (GGT) | ɤ-glutamyltranspeptidase (GGT) in U/L | At baseline and 12th week | 
| Demonstrate changes in Direct bilirubin | Direct bilirubin in mg/dl | At baseline and 12th week | 
| Demonstrate changes in the Lipid values | Total cholesterol(TC) in mg/dl , Triglycerides(TG) in mg/dl , LDL-Cholesterol in mg/dl , HDL-Cholesterol in mg/dl | At baseline and 12th week | 
| Demonstrate changes in the body weight and body mass index (BMI) | BMI in kg/m^2 will be calculated using the formula: BMI= [Weight (kg)/Height (m2)]. | At baseline and 12th week | 
| Demonstrate changes in the Inflammatory marker : CRP | C-reactive protein in mg/L | At baseline and 12th week | 
| Demonstrate changes in Serum cytokeratin 18 (Ck-18) | Serum cytokeratin 18 (Ck-18) will be determined by Enzyme-linked Immunosorbent assay kits. | At baseline and 12th week | 
| Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1) | Serum transforming growth factor-beta1 (TGF-β1) will be determined by Enzyme-linked Immunosorbent assay kits. | At baseline and 12th week | 
| Serum Retinol binding protein 4 (RBP-4) | Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits. | At baseline and 12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statin, nonalcoholic steatohepatitis, NASH, NAFLD, Non-Alcoholic Fatty Liver Disease, Rosuvastatin, Coenzyme Q10, Fatty Liver, Liver Diseases