[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514918":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":12,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":12,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":12,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","Patients will receive the standard conventional care which is mainly therapeutic life changes",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Test Group","EXPERIMENTAL","Patients will receive Coenzyme Q10 Forte® (MEPACO Pharmaceutical Company, Cairo, Egypt) capsules in a dose of 100 mg twice per day 1 capsule every 12 hours for twelve weeks, in addition to the standard conventional care.",[18],"Drug: Coenzyme Q10 Forte® capsules",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Coenzyme Q10 Forte® capsules","Coenzyme Q10 in the form of soft gelatin capsules, each capsule containing 100 mg",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Mariam Seif","CONTACT","+201112720114","mariam.talaat@pharma.asu.edu.eg",[32],{"facility":33,"status":34,"city":35,"state":12,"zip":12,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"National Hepatology and tropical medicine research institute","RECRUITING","Cairo","Egypt","EG",{"type":39,"coordinates":40},"Point",[41,42],31.24967,30.06263,{"lat":42,"lon":41},[45],{"name":12,"role":28,"phone":46,"phoneExt":47,"email":48},"23642494","02","info@nhtmri.org",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Mariam Talaat","Principal Investigator","100514918","phase-2-effect-of-coq10-on-the-outcome-of-mafld-patients-100514918",false,"NCT05984745","Effect of CoQ10 on the Outcome of MAFLD Patients","Effect of Coenzyme Q10 on the Outcome of Metabolic Dysfunction-Associated Fatty Liver Disease Patients","Inclusion Criteria:\n\nAll study subjects and prior to consenting to the ICF, laboratory and imaging work-up will be evaluated for the presence of three out of five criteria for metabolic dysregulation in the context of metabolic -dysfunction associated fatty liver disease (MAFLD):\n\n1. Waist circumference (WC) ≥ 102\u002F88 cm for men and women respectively.\n2. HDL cholesterol \\\u003C40 mg\u002Fdl in men and \\\u003C50 mg\u002Fdl in women or on specific drug therapy.\n3. Plasma Triglycerides ≥ 150 mg\u002Fdl or on specific drug therapy.\n4. Blood pressure ≥130 and\u002For ≥ 85 or on specific anti-hypertensive therapy.\n5. Fasting blood glucose ≥ 100 mg\u002Fdl or on specific anti hyperglycemic therapy\n\n   * Patients who agree to sign an informed consent\n   * Adult patients \\>18 years old.\n   * Males and females\n   * Willing to comply with procedures and follow up\n   * Elevated serum transaminases (1-4 times the ULN)\n   * Imaging evidence of fatty liver:\n\npelviabdominal ultrasound and Fibro- CAP study\n\nExclusion Criteria:\n\n* Pregnancy or lactating\n* Physical or mental abnormalities\n* HCV infection\n* HBV infection\n* Anaemia\n* Thrombocytopenia\n* Haematological malignancies\n* Ongoing alcoholism (Male: \\>30g\u002Fday, Female: \\>20g\u002Fday)\n* Patients with renal failure\n* Autoimmune hepatitis\n* Celiac disease\n* Wilson's disease\n* Hemochromatosis\n* Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants, All anti-oxidative stress agents, Cos, IUD\n* Chronic use of systematically immunosuppressive agent or drugs that can affect liver profile.\n* Hypo\u002FHyper-thyroidism\n* Bypass surgeries\n* TPN (Total Parenteral Nutrition)","ALL","18 Years","80 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","So far there has been no universal treatment for MAFLD since it has a complex etiology that involves ethnic, genetic, metabolic and environmental factors. However, therapeutic life changes including: diet, weight loss, and physical activity remain the cornerstone of treatment and is recommended by both American and European associations.\n\nInflammatory biomarkers, such as tumor necrosis factor-alpha, and adipokines play key roles in the pathogenesis of MAFLD, hence, the anti-inflammatory and antioxidant effects of coenzyme Q10 especially at high doses that have not been tested are hypothesized to have a beneficial role in improving the systemic inflammation and biochemical variables.\n\nThis study is conducted to test this hypothesis",[71,72],"Fatty Liver","NAFLD",[74,75,76,71,77,78,79,80,81],"Coenzyme Q10","Liver steatosis","TNF alpha","Inflammation","MAFLD","CoQ10","Ubiquinone","Liver Disease","2025-03-22",{"date":84,"type":85},"2025-03-26","ACTUAL",{"date":87,"type":85},"2023-10-31",{"date":89,"type":65},"2025-12",{"name":5,"class":6},1]