Clinical trial NCT05731596: Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis
Official title: Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Rosuvastatin Versus Coenzyme Q10 on Nonalcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nonalcoholic Steatohepatitis
Keywords: nonalcoholic steatohepatitis
NASH
NAFLD
Non-Alcoholic Fatty Liver Disease
Rosuvastatin
Coenzyme Q10
Fatty Liver
statin
Liver Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in liver stiffness measurement (LSM)
timeFrame: At baseline and 12th week
measure: Change in ultrasound score
timeFrame: At baseline and 12th week
Secondary outcomes:
measure: Demonstrate changes in Alanine aminotransferase (ALT)
timeFrame: At baseline and 12th week
measure: Demonstrate changes in Aspartate aminotransferase (AST)
timeFrame: At baseline and 12th week
measure: Demonstrate changes in Alkaline phosphatase (ALP)
timeFrame: At baseline and 12th week
measure: Demonstrate changes in ɤ-glutamyltranspeptidase (GGT)
timeFrame: At baseline and 12th week
measure: Demonstrate changes in Direct bilirubin
timeFrame: At baseline and 12th week
measure: Demonstrate changes in the Lipid values
timeFrame: At baseline and 12th week
measure: Demonstrate changes in the body weight and body mass index (BMI)
timeFrame: At baseline and 12th week
measure: Demonstrate changes in the Inflammatory marker : CRP
timeFrame: At baseline and 12th week
measure: Demonstrate changes in Serum cytokeratin 18 (Ck-18)
timeFrame: At baseline and 12th week
measure: Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1)
timeFrame: At baseline and 12th week
measure: Serum Retinol binding protein 4 (RBP-4)
timeFrame: At baseline and 12th week
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of pharmacy , Pharos University
name: Hadeer Ahmed Alsayed, B.Sc. Degree
role: PRINCIPAL_INVESTIGATOR
References:
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