Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Rosuvastatin Versus Coenzyme Q10 on Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- Change in liver stiffness measurement (LSM)
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 years.
- •Gender: Both male and female patients will be included.
- •Patients have established diagnosis of NASH (based on liver ultrasonography).
排除标准
- •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.
研究组 & 干预措施
Group 1 (Rosuvastatin group)
Patients will receive Rosuvastatin 20mg/day orally for 3 months
干预措施: Rosuvastatin 20 Mg Oral Tablet (Drug)
Group 2 (CoQ10 group)
Patients will receive Coenzyme Q10 100 mg/day orally for 3 months
干预措施: Coenzyme Q10 100 MG Oral Capsule (Drug)
结局指标
主要结局
Change in liver stiffness measurement (LSM)
时间窗: At baseline and 12th week
LSM will be assessed by Fibro scan
Change in ultrasound score
时间窗: At baseline and 12th week
Ultrasound score will be assessed by Ultrasonography
次要结局
- Demonstrate changes in the body weight and body mass index (BMI)(At baseline and 12th week)
- Demonstrate changes in the Inflammatory marker : CRP(At baseline and 12th week)
- Demonstrate changes in Alanine aminotransferase (ALT)(At baseline and 12th week)
- Demonstrate changes in Aspartate aminotransferase (AST)(At baseline and 12th week)
- Demonstrate changes in Alkaline phosphatase (ALP)(At baseline and 12th week)
- Demonstrate changes in ɤ-glutamyltranspeptidase (GGT)(At baseline and 12th week)
- Demonstrate changes in Direct bilirubin(At baseline and 12th week)
- Demonstrate changes in the Lipid values(At baseline and 12th week)
- Demonstrate changes in Serum cytokeratin 18 (Ck-18)(At baseline and 12th week)
- Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1)(At baseline and 12th week)
- Serum Retinol binding protein 4 (RBP-4)(At baseline and 12th week)
研究者
Hadeer Ahmed Alsayed
Principal Investigator
Tanta University