[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659284":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":35,"studyPopulation":23,"armGroups":36,"interventions":54,"overallOfficials":23,"centralContacts":68,"locations":78,"responsibleParty":91,"collaborators":23,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":23,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":118,"whyStopped":23,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Kafrelsheikh University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":23},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"mRNA Expression for inflammasome activity","TGF-β1 and IL-1β","24 weeks",{"measure":14,"description":15,"timeFrame":12},"Oxidative stress markers","MDA",{"measure":17,"description":18,"timeFrame":12},"NLRP3 inflammasome activation","NLRP3 protein",[20],{"measure":21,"description":22,"timeFrame":12},"Liver enzymes","ALT\u002F AST",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of three parallel groups: vitamin E, silymarin, or placebo.","TREATMENT",{"masking":30,"maskingDescription":31,"whoMasked":32},"DOUBLE","Placebo group",[33,34],"PARTICIPANT","CARE_PROVIDER","To evaluate the efficacy of vitamin E (800 IU\u002Fday) versus silymarin (420 mg\u002Fday, divided TID) in modulating MASLD-associated mRNA expression, NLRP3 inflammasome levels, and MDA in adult patients with MASLD",[37,43,48],{"label":38,"type":39,"description":40,"interventionNames":41},"Vitamin E Group","ACTIVE_COMPARATOR","Participants in vitamin E group will receive vitamin E 800 IU\u002Fday for 24 weeks",[42],"Drug: Vitamin E 800 IU\u002Fd",{"label":44,"type":39,"description":45,"interventionNames":46},"Silymarin Group","Participants in Silymarin group will receive silymarin 420 mg\u002Fd for 24 weeks",[47],"Drug: Silymarin 420 mg",{"label":49,"type":50,"description":51,"interventionNames":52},"Placebo Group","PLACEBO_COMPARATOR","Participants in Placebo group will receive matching placebo for 24 weeks",[53],"Drug: Placebo",[55,60,64],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":23},"DRUG","Vitamin E 800 IU\u002Fd","Participants in Vitamin E Group will receive oral vitamin E at dose of 800 IU\u002Fd for a total duration of 24 weeks",[38],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":23},"Silymarin 420 mg","Participants in Silymarin Group will receive oral silymarin at dose of 420 mg\u002Fd for a total duration of 24 weeks",[44],{"type":56,"name":65,"description":66,"armGroupLabels":67,"otherNames":23},"Placebo","participants in Placebo Group will receive an oral placebo capsule, identical in appearance to the active interventions once daily for 24 weeks",[49],[69,74],{"name":70,"role":71,"phone":72,"phoneExt":23,"email":73},"Noha M El-Khodary, Associate Professor","CONTACT","+01283950155","noha_mahmoud@pharm.kfs.edu.eg",{"name":75,"role":71,"phone":76,"phoneExt":23,"email":77},"Amr Y. Zakaria, Lecturer","+01127744748","ahamza@horus.edu.eg",[79],{"facility":80,"status":23,"city":81,"state":23,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":23},"Faculty of Medicine","Tanta","31511","Egypt","EG",{"type":86,"coordinates":87},"Point",[88,89],31.00192,30.78847,{"lat":89,"lon":88},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Noha Mahmoud El-Khodary","Associate Professor","100659284","phase-3-vitamin-e-versus-silymarin-in-non-diabetic-masld-patients-100659284",false,"NCT07863648","Vitamin E Versus Silymarin in Non Diabetic MASLD Patients","A Randomized Controlled Evaluation of Vitamin E Versus Silymarin on Liver Through Modulation of mRNA Profiles, NLRP3 Inflammasome Signaling, and Oxidative Stress in Non Diabetic MASLD Patients","MASLD","Inclusion Criteria:\n\n* Adults (18-65 y),\n* Diagnosed with MASLD (CAP ≥248 dB\u002Fm on FibroScan, ALT \\>40 IU\u002FL),\n* Non-diabetic (HbA1c \\\u003C6.5%, fasting glucose \\\u003C126 mg\u002FdL),\n* BMI 25-40 kg\u002Fm²,\n* No alcohol (\\>20 g\u002Fd women, \\>30 g\u002Fd men).\n\nExclusion Criteria:\n\n* Cirrhosis (LSM \\>12 kPa),\n* Decompensated liver disease,\n* Other liver diseases, decompensated cirrhosis,\n* Pregnancy, or\n* use of vitamin E\u002Fsilymarin within 3 months.","ALL","18 Years","65 Years",{"count":107,"type":108},120,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), is a chronic liver condition marked by excessive fat buildup (steatosis) in liver cells, linked to at least one metabolic risk factor like obesity, type 2 diabetes, high blood lipids, or hypertension. Vitamin E serves as a recommended antioxidant therapy for select MASLD patients. It reduces liver inflammation markers such as ALT and AST, alongside benefits in steatosis and MASH resolution. Silymarin has clinical evidence supports its use as an adjunctive hepatoprotective agent due to antioxidant, anti-inflammatory, and antifibrotic effects.",[114],"Metabolic Dysfunction-Associated Steatoic Liver Disease",[15,116,117],"TGF-β1","NLRP3","NOT_YET_RECRUITING","2026-10-07",{"date":121,"type":122},"2026-10-13","ACTUAL",{"date":124,"type":108},"2026-10-16",{"date":126,"type":108},"2027-09-01",{"name":5,"class":6},1]