Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- Drug: Coenzyme Q10 100 MG Oral Capsule
- Registration Number
- NCT05731596
- Lead Sponsor
- Tanta University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 46
- Age: ≥ 18 years.
- Gender: Both male and female patients will be included.
- Patients have established diagnosis of NASH (based on liver ultrasonography).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (Rosuvastatin group) Rosuvastatin 20 Mg Oral Tablet Patients will receive Rosuvastatin 20mg/day orally for 3 months Group 2 (CoQ10 group) Coenzyme Q10 100 MG Oral Capsule Patients will receive Coenzyme Q10 100 mg/day orally for 3 months
- Primary Outcome Measures
Name Time Method Change in liver stiffness measurement (LSM) At baseline and 12th week LSM will be assessed by Fibro scan
Change in ultrasound score At baseline and 12th week Ultrasound score will be assessed by Ultrasonography
- Secondary Outcome Measures
Name Time Method Demonstrate changes in the body weight and body mass index (BMI) At baseline and 12th week BMI in kg/m\^2 will be calculated using the formula: BMI= \[Weight (kg)/Height (m2)\].
Demonstrate changes in the Inflammatory marker : CRP At baseline and 12th week C-reactive protein in mg/L
Demonstrate changes in Alanine aminotransferase (ALT) At baseline and 12th week Alanine aminotransferase (ALT) in U/L
Demonstrate changes in Aspartate aminotransferase (AST) At baseline and 12th week Aspartate aminotransferase (AST) in U/L
Demonstrate changes in Alkaline phosphatase (ALP) At baseline and 12th week Alkaline phosphatase (ALP) in U/L
Demonstrate changes in ɤ-glutamyltranspeptidase (GGT) At baseline and 12th week ɤ-glutamyltranspeptidase (GGT) in U/L
Demonstrate changes in Direct bilirubin At baseline and 12th week Direct bilirubin in mg/dl
Demonstrate changes in the Lipid values At baseline and 12th week Total cholesterol(TC) in mg/dl , Triglycerides(TG) in mg/dl , LDL-Cholesterol in mg/dl , HDL-Cholesterol in mg/dl
Demonstrate changes in Serum cytokeratin 18 (Ck-18) At baseline and 12th week Serum cytokeratin 18 (Ck-18) will be determined by Enzyme-linked Immunosorbent assay kits.
Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1) At baseline and 12th week Serum transforming growth factor-beta1 (TGF-β1) will be determined by Enzyme-linked Immunosorbent assay kits.
Serum Retinol binding protein 4 (RBP-4) At baseline and 12th week Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits.