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

May 13, 2023 updated by: Hadeer Ahmed Alsayed, Tanta University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver stiffness measurement (LSM)
Time Frame: At baseline and 12th week
LSM will be assessed by Fibro scan
At baseline and 12th week
Change in ultrasound score
Time Frame: At baseline and 12th week
Ultrasound score will be assessed by Ultrasonography
At baseline and 12th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate changes in Alanine aminotransferase (ALT)
Time Frame: At baseline and 12th week
Alanine aminotransferase (ALT) in U/L
At baseline and 12th week
Demonstrate changes in Aspartate aminotransferase (AST)
Time Frame: At baseline and 12th week
Aspartate aminotransferase (AST) in U/L
At baseline and 12th week
Demonstrate changes in Alkaline phosphatase (ALP)
Time Frame: At baseline and 12th week
Alkaline phosphatase (ALP) in U/L
At baseline and 12th week
Demonstrate changes in ɤ-glutamyltranspeptidase (GGT)
Time Frame: At baseline and 12th week
ɤ-glutamyltranspeptidase (GGT) in U/L
At baseline and 12th week
Demonstrate changes in Direct bilirubin
Time Frame: At baseline and 12th week
Direct bilirubin in mg/dl
At baseline and 12th week
Demonstrate changes in the Lipid values
Time Frame: 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
At baseline and 12th week
Demonstrate changes in the body weight and body mass index (BMI)
Time Frame: At baseline and 12th week
BMI in kg/m^2 will be calculated using the formula: BMI= [Weight (kg)/Height (m2)].
At baseline and 12th week
Demonstrate changes in the Inflammatory marker : CRP
Time Frame: At baseline and 12th week
C-reactive protein in mg/L
At baseline and 12th week
Demonstrate changes in Serum cytokeratin 18 (Ck-18)
Time Frame: At baseline and 12th week
Serum cytokeratin 18 (Ck-18) will be determined by Enzyme-linked Immunosorbent assay kits.
At baseline and 12th week
Demonstrate changes in Serum transforming growth factor-beta1 (TGF-β1)
Time Frame: At baseline and 12th week
Serum transforming growth factor-beta1 (TGF-β1) will be determined by Enzyme-linked Immunosorbent assay kits.
At baseline and 12th week
Serum Retinol binding protein 4 (RBP-4)
Time Frame: At baseline and 12th week
Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits.
At baseline and 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Hadeer Ahmed Alsayed, B.Sc. Degree, Faculty of pharmacy , Pharos University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 13, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rosuvastatin vs Co Q10 on NASH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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