Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis
NCT ID: NCT05731596
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
46 participants
INTERVENTIONAL
2023-06-30
2024-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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
TREATMENT
NONE
Study Groups
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Group 1 (Rosuvastatin group)
Patients will receive Rosuvastatin 20mg/day orally for 3 months
Rosuvastatin 20 Mg Oral Tablet
Rosuvastatin 20 mg will be administered orally once daily for 3 Months
Group 2 (CoQ10 group)
Patients will receive Coenzyme Q10 100 mg/day orally for 3 months
Coenzyme Q10 100 MG Oral Capsule
Coenzyme Q10 100 mg will be administered orally once daily for 3 Months
Interventions
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Rosuvastatin 20 Mg Oral Tablet
Rosuvastatin 20 mg will be administered orally once daily for 3 Months
Coenzyme Q10 100 MG Oral Capsule
Coenzyme Q10 100 mg will be administered orally once daily for 3 Months
Eligibility Criteria
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Inclusion Criteria
* Gender: Both male and female patients will be included.
* Patients have established diagnosis of NASH (based on liver ultrasonography).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Hadeer Ahmed Alsayed
Principal Investigator
Principal Investigators
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Hadeer Ahmed Alsayed, B.Sc. Degree
Role: PRINCIPAL_INVESTIGATOR
Faculty of pharmacy , Pharos University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Rosuvastatin vs Co Q10 on NASH
Identifier Type: -
Identifier Source: org_study_id
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