Nonalcoholic Steatohepatitis
Conditions
Keywords
nonalcoholic steatohepatitis, NASH, NAFLD, Non-Alcoholic Fatty Liver Disease, Rosuvastatin, Coenzyme Q10, Fatty Liver, statin, Liver Diseases
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.
Interventions
Rosuvastatin 20 mg will be administered orally once daily for 3 Months
DRUGCoenzyme Q10 100 MG Oral Capsule
Coenzyme Q10 100 mg will be administered orally once daily for 3 Months
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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: 1. Group 1(n=23): patients will receive Rosuvastatin 20mg/day orally 2. Group 2(n=23): patients will receive Coenzyme Q10 100 mg/day orally
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Alanine aminotransferase (ALT) | At baseline and 12th week | Alanine aminotransferase (ALT) in U/L |
| Demonstrate changes in the Inflammatory marker : CRP | At baseline and 12th week | C-reactive protein in mg/L |
| 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. |
| 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 Aspartate aminotransferase (AST) | At baseline and 12th week | Aspartate aminotransferase (AST) in U/L |
Contacts
Primary ContactHadeer Ahmed Alsayed, B.Sc. Degree
Outcome results
None listed