[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643834":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"Hong Kong Baptist University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LJF group","EXPERIMENTAL","Subjects in the LJF group will receive oral LJF capsules, 3 capsules per dose (0.4 g per capsule; total 1.2 g), administered twice daily for a duration of 24 weeks.",[13],"Drug: Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Subjects in the placebo group will receive placebo capsules, 3 capsules per dose (0.4 g per capsule; total 1.2 g), administered twice daily for a duration of 24 weeks.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF)","Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) is composed of five herbs (e.g., Salviae Miltiorrhizae Radix et Rhizoma, Puerariae Lobatae Radix).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","The placebo contains caramel color, sucrose octaacetate, sucralose, etc.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jialing ZHANG, PhD","CONTACT","852-34115024","zhangjialing@hkbu.edu.hk",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","ZhaoXiang Bian","Professor","100643834","phase-2-linzhi-jianghuang-fufang-huoxue-anshen-capsule-for-non-alcoholic-fatty-liver-100643834",false,"NCT07637006","Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver","The Efficacy and Safety of Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver: a Randomized, Double-blinded, Placebo-controlled Trial","LJF","Inclusion Criteria:\n\n* 1\\) Age between 18 and 65 years (inclusive);\n* 2\\) Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 10%;\n* 3\\) Liver stiffness measured by transient elastography \\\u003C 7.3 kPa;\n* 4\\) Presence of one or more metabolic risk factors: a. Fasting plasma glucose ≥ 6.1 mmol\u002FL, or 2-hour postprandial glucose ≥ 7.8 mmol\u002FL, or HbA1c ≥ 5.7%, or a history of type 2 diabetes, or HOMA-IR ≥ 2.5; b. Arterial blood pressure ≥ 130\u002F85 mmHg, or receiving antihypertensive medication; c. Fasting serum triglycerides ≥ 1.7 mmol\u002FL;\n* 5\\) Diagnosis of NAFLD with Phlegm-Stasis Obstructing Collateral pattern according to Traditional Chinese Medicine (TCM) criteria, formulated based on the \"Consensus Opinion on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease (2017)\": Primary Symptoms: a. Intercostal stabbing or dull pain; b. Palpable abdominal mass (hypochondriac mass); c. Dark or dull complexion; d. Obesity. Secondary Symptoms: a. Epigastric and chest fullness and oppression; b. Expectoration of sputum; c. Poor appetite and aversion to greasy food; d. Heavy sensation in the limbs. Tongue and Pulse: Dark red tongue with ecchymosis, enlarged tongue body with teeth marks, greasy coating; wiry, slippery, or hesitant pulse. Diagnosis can be established with the presence of at least 2 primary symptoms and 1 or 2 secondary symptoms, in conjunction with the tongue and pulse presentation.\n* 6\\) Understand the trial content thoroughly and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Excessive alcohol intake (converted pure alcohol \\> 210 g per week for men, \\> 140 g per week for women), or an Alcohol Use Disorder Identification Test (AUDIT) score ≥ 8;\n* 2\\) Other liver diseases (e.g., alcoholic hepatitis, viral hepatitis, drug-induced liver disease, Wilson's disease, autoimmune liver disease, etc.), or a history of liver transplantation or liver resection;\n* 3\\) Presence of severe concurrent diseases affecting the heart, brain, hematopoietic system, immune system, or kidneys (BUN \\> 1.5 × ULN, Cr \\> ULN);\n* 4\\) Presence of other endocrine system disorders, such as hyperthyroidism, Cushing's syndrome, etc.;\n* 5\\) History of malignancy that has not been in complete remission for more than 5 years;\n* 6\\) Hepatic decompensation (total bilirubin, platelet count, prothrombin time, albumin \\> ULN; ALT or AST \\> 2 × ULN), presence of ascites, varices, or a history of hepatic encephalopathy;\n* 7\\) Poorly controlled severe hypertension, defined as systolic blood pressure ≥ 180 mmHg and\u002For diastolic blood pressure ≥ 110 mmHg;\n* 8\\) Insulin-dependent diabetes mellitus (e.g., type 1 diabetes mellitus, or current use of insulin), or non-insulin-dependent diabetes mellitus with poor glycemic control (HbA1c ≥ 9.5%), or diabetic acute complications, or diabetes with severe chronic complications;\n* 9\\) Use of medications that may cause hepatic steatosis or steatohepatitis (e.g., tamoxifen, amiodarone, glucocorticoids, tetracyclines, methotrexate, valproate, salicylates, estrogens) or potentially hepatotoxic drugs for 2 consecutive weeks or more within the past year;\n* 10\\) Current use or use within the past 3 months of GLP-1 receptor agonists;\n* 11\\) Adjustment of hypoglycemic, antihypertensive, or lipid-lowering medications within the past 3 months (e.g., adding or discontinuing medication, dose change, or irregular use);\n* 12\\) Regular use of hepatoprotective drugs or vitamin E within the past month;\n* 13\\) History of bariatric surgery within the past year, or body weight change \\> 5% within the past 3 months;\n* 14\\) History of surgery within the past month;\n* 15\\) Coagulation abnormalities, or current use of medications or foods with anticoagulant effects (e.g., aspirin, warfarin, Panax notoginseng, safflower, Angelica sinensis, peach kernel, etc.);\n* 16\\) Concomitant psychiatric or psychological disorders, or substance\u002Fdrug abuse;\n* 17\\) Known allergic constitution, or known allergy to any component of LJF;\n* 18\\) Participation in another clinical trial within the past month;\n* 19\\) Contraindications for MRI examination, such as claustrophobia or presence of metallic implants;\n* 20\\) Individuals of childbearing potential (male or female) with fertility plans; pregnant or lactating women.","ALL","18 Years","65 Years",{"count":53,"type":54},180,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","This is a randomized, double-blinded, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) for non-alcoholic fatty liver.",[60],"Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)",[62,63,64,65,66],"Non-alcoholic fatty liver","Traditional Chinese medicine","Non-alcoholic fatty liver disease","Metabolic dysfunction-associated fatty liver disease","Linzhi Jianghuang Fufang Huoxue Anshen Capsule","NOT_YET_RECRUITING","2026-06-07",{"date":70,"type":71},"2026-06-09","ACTUAL",{"date":73,"type":54},"2026-09",{"date":75,"type":54},"2029-01",{"name":5,"class":6}]