Back to resultsComparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis
Primary Purpose
Nonalcoholic Steatohepatitis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin 20 Mg Oral Tablet
Coenzyme Q10 100 MG Oral Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring nonalcoholic steatohepatitis, NASH, NAFLD, Non-Alcoholic Fatty Liver Disease, Rosuvastatin, Coenzyme Q10, Fatty Liver, statin, Liver Diseases
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1 (Rosuvastatin group)
Group 2 (CoQ10 group)
Arm Description
Patients will receive Rosuvastatin 20mg/day orally for 3 months
Patients will receive Coenzyme Q10 100 mg/day orally for 3 months
Outcomes
Primary Outcome Measures
Change in liver stiffness measurement (LSM)
LSM will be assessed by Fibro scan
Change in ultrasound score
Ultrasound score will be assessed by Ultrasonography
Secondary Outcome Measures
Demonstrate changes in Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT) in U/L
Demonstrate changes in Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) in U/L
Demonstrate changes in Alkaline phosphatase (ALP)
Alkaline phosphatase (ALP) in U/L
Demonstrate changes in ɤ-glutamyltranspeptidase (GGT)
ɤ-glutamyltranspeptidase (GGT) in U/L
Demonstrate changes in Direct bilirubin
Direct bilirubin in mg/dl
Demonstrate changes in the Lipid values
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)
BMI in kg/m^2 will be calculated using the formula: BMI= [Weight (kg)/Height (m2)].
Demonstrate changes in the Inflammatory marker : CRP
C-reactive protein in mg/L
Demonstrate changes in Serum cytokeratin 18 (Ck-18)
Serum cytokeratin 18 (Ck-18) will be determined by Enzyme-linked Immunosorbent assay kits.
Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1)
Serum transforming growth factor-beta1 (TGF-β1) will be determined by Enzyme-linked Immunosorbent assay kits.
Serum Retinol binding protein 4 (RBP-4)
Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05731596
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis
Keywords
nonalcoholic steatohepatitis, NASH, NAFLD, Non-Alcoholic Fatty Liver Disease, Rosuvastatin, Coenzyme Q10, Fatty Liver, statin, Liver Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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 orally
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Rosuvastatin group)
Arm Type
Active Comparator
Arm Description
Patients will receive Rosuvastatin 20mg/day orally for 3 months
Arm Title
Group 2 (CoQ10 group)
Arm Type
Experimental
Arm Description
Patients will receive Coenzyme Q10 100 mg/day orally for 3 months
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20 Mg Oral Tablet
Intervention Description
Rosuvastatin 20 mg will be administered orally once daily for 3 Months
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10 100 MG Oral Capsule
Intervention Description
Coenzyme Q10 100 mg will be administered orally once daily for 3 Months
Primary Outcome Measure Information:
Title
Change in liver stiffness measurement (LSM)
Description
LSM will be assessed by Fibro scan
Time Frame
At baseline and 12th week
Title
Change in ultrasound score
Description
Ultrasound score will be assessed by Ultrasonography
Time Frame
At baseline and 12th week
Secondary Outcome Measure Information:
Title
Demonstrate changes in Alanine aminotransferase (ALT)
Description
Alanine aminotransferase (ALT) in U/L
Time Frame
At baseline and 12th week
Title
Demonstrate changes in Aspartate aminotransferase (AST)
Description
Aspartate aminotransferase (AST) in U/L
Time Frame
At baseline and 12th week
Title
Demonstrate changes in Alkaline phosphatase (ALP)
Description
Alkaline phosphatase (ALP) in U/L
Time Frame
At baseline and 12th week
Title
Demonstrate changes in ɤ-glutamyltranspeptidase (GGT)
Description
ɤ-glutamyltranspeptidase (GGT) in U/L
Time Frame
At baseline and 12th week
Title
Demonstrate changes in Direct bilirubin
Description
Direct bilirubin in mg/dl
Time Frame
At baseline and 12th week
Title
Demonstrate changes in the Lipid values
Description
Total cholesterol(TC) in mg/dl , Triglycerides(TG) in mg/dl , LDL-Cholesterol in mg/dl , HDL-Cholesterol in mg/dl
Time Frame
At baseline and 12th week
Title
Demonstrate changes in the body weight and body mass index (BMI)
Description
BMI in kg/m^2 will be calculated using the formula: BMI= [Weight (kg)/Height (m2)].
Time Frame
At baseline and 12th week
Title
Demonstrate changes in the Inflammatory marker : CRP
Description
C-reactive protein in mg/L
Time Frame
At baseline and 12th week
Title
Demonstrate changes in Serum cytokeratin 18 (Ck-18)
Description
Serum cytokeratin 18 (Ck-18) will be determined by Enzyme-linked Immunosorbent assay kits.
Time Frame
At baseline and 12th week
Title
Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1)
Description
Serum transforming growth factor-beta1 (TGF-β1) will be determined by Enzyme-linked Immunosorbent assay kits.
Time Frame
At baseline and 12th week
Title
Serum Retinol binding protein 4 (RBP-4)
Description
Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits.
Time Frame
At baseline and 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadeer Ahmed Alsayed, B.Sc. Degree
Phone
00201011611651
Email
hader.ahmed41996@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadeer Ahmed Alsayed, B.Sc. Degree
Organizational Affiliation
Faculty of pharmacy , Pharos University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis
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