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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Rosuvastatin group) | Active Comparator | Patients will receive Rosuvastatin 20mg/day orally for 3 months |
|
| Group 2 (CoQ10 group) | Experimental | Patients will receive Coenzyme Q10 100 mg/day orally for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 20 Mg Oral Tablet | Drug | Rosuvastatin 20 mg will be administered orally once daily for 3 Months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver stiffness measurement (LSM) | LSM will be assessed by Fibro scan | At baseline and 12th week |
| Change in ultrasound score | Ultrasound score will be assessed by Ultrasonography | At baseline and 12th week |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate changes in Alanine aminotransferase (ALT) | Alanine aminotransferase (ALT) in U/L | At baseline and 12th week |
| Demonstrate changes in Aspartate aminotransferase (AST) | Aspartate aminotransferase (AST) in U/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadeer Ahmed Alsayed, B.Sc. Degree | Contact | 00201011611651 | hader.ahmed41996@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hadeer Ahmed Alsayed, B.Sc. Degree | Faculty of pharmacy , Pharos University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26707365 | Background | Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22. | |
| 29886156 | Background | Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D013607 | Tablets |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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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:
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| Coenzyme Q10 100 MG Oral Capsule | Drug | Coenzyme Q10 100 mg will be administered orally once daily for 3 Months |
|
| At baseline and 12th week |
| Demonstrate changes in Alkaline phosphatase (ALP) | Alkaline phosphatase (ALP) in U/L | At baseline and 12th week |
| Demonstrate changes in ɤ-glutamyltranspeptidase (GGT) | ɤ-glutamyltranspeptidase (GGT) in U/L | At baseline and 12th week |
| Demonstrate changes in Direct bilirubin | Direct bilirubin in mg/dl | At baseline and 12th week |
| 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 | At baseline and 12th week |
| 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)]. | At baseline and 12th week |
| Demonstrate changes in the Inflammatory marker : CRP | C-reactive protein in mg/L | At baseline and 12th week |
| Demonstrate changes in Serum cytokeratin 18 (Ck-18) | 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) | 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) | Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits. | At baseline and 12th week |
| 32006558 | Background | Mantovani A, Scorletti E, Mosca A, Alisi A, Byrne CD, Targher G. Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism. 2020 Oct;111S:154170. doi: 10.1016/j.metabol.2020.154170. Epub 2020 Jan 30. |
| 25125077 | Background | Ekstedt M, Hagstrom H, Nasr P, Fredrikson M, Stal P, Kechagias S, Hultcrantz R. Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up. Hepatology. 2015 May;61(5):1547-54. doi: 10.1002/hep.27368. Epub 2015 Mar 23. |
| 28714183 | Background | Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available. |
| 26378641 | Background | Vanni E, Marengo A, Mezzabotta L, Bugianesi E. Systemic Complications of Nonalcoholic Fatty Liver Disease: When the Liver Is Not an Innocent Bystander. Semin Liver Dis. 2015 Aug;35(3):236-49. doi: 10.1055/s-0035-1562944. Epub 2015 Sep 17. |
| 27484755 | Background | Spahillari A, Mukamal KJ, DeFilippi C, Kizer JR, Gottdiener JS, Djousse L, Lyles MF, Bartz TM, Murthy VL, Shah RV. The association of lean and fat mass with all-cause mortality in older adults: The Cardiovascular Health Study. Nutr Metab Cardiovasc Dis. 2016 Nov;26(11):1039-1047. doi: 10.1016/j.numecd.2016.06.011. Epub 2016 Jun 28. |
| 35126843 | Background | Tzanaki I, Agouridis AP, Kostapanos MS. Is there a role of lipid-lowering therapies in the management of fatty liver disease? World J Hepatol. 2022 Jan 27;14(1):119-139. doi: 10.4254/wjh.v14.i1.119. |
| 24098525 | Background | Wang W, Zhao C, Zhou J, Zhen Z, Wang Y, Shen C. Simvastatin ameliorates liver fibrosis via mediating nitric oxide synthase in rats with non-alcoholic steatohepatitis-related liver fibrosis. PLoS One. 2013 Oct 2;8(10):e76538. doi: 10.1371/journal.pone.0076538. eCollection 2013. |
| 21083855 | Background | Pramfalk C, Parini P, Gustafsson U, Sahlin S, Eriksson M. Effects of high-dose statin on the human hepatic expression of genes involved in carbohydrate and triglyceride metabolism. J Intern Med. 2011 Mar;269(3):333-9. doi: 10.1111/j.1365-2796.2010.02305.x. Epub 2010 Nov 18. |
| 26156412 | Background | Farsi F, Mohammadshahi M, Alavinejad P, Rezazadeh A, Zarei M, Engali KA. Functions of Coenzyme Q10 Supplementation on Liver Enzymes, Markers of Systemic Inflammation, and Adipokines in Patients Affected by Nonalcoholic Fatty Liver Disease: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Am Coll Nutr. 2016 May-Jun;35(4):346-53. doi: 10.1080/07315724.2015.1021057. Epub 2015 Jul 9. |
| 30675881 | Background | Chen K , Chen X , Xue H , Zhang P , Fang W , Chen X , Ling W . Coenzyme Q10 attenuates high-fat diet-induced non-alcoholic fatty liver disease through activation of the AMPK pathway. Food Funct. 2019 Feb 20;10(2):814-823. doi: 10.1039/c8fo01236a. |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |