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

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05731596

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nonalcoholic Steatohepatitis	Drug: Rosuvastatin 20 Mg Oral Tablet Drug: Coenzyme Q10 100 MG Oral Capsule	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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: Group 1(n=23): patients will receive Rosuvastatin 20mg/day orally Group 2(n=23): patients will receive Coenzyme Q10 100 mg/day orallyThis study will be a randomized, controlled, parallel study. It will be conducted on 46 patients diagnosed with NASHThe 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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Group 1 (Rosuvastatin group)

Patients will receive Rosuvastatin 20mg/day orally for 3 months

Drug: Rosuvastatin 20 Mg Oral Tablet

Rosuvastatin 20 mg will be administered orally once daily for 3 Months

Experimental: Group 2 (CoQ10 group)

Patients will receive Coenzyme Q10 100 mg/day orally for 3 months

Drug: Coenzyme Q10 100 MG Oral Capsule

Coenzyme Q10 100 mg will be administered orally once daily for 3 Months

Outcome Measures

Primary Outcome Measures

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

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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.