Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver

Official title

The Efficacy and Safety of Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver: a Randomized, Double-blinded, Placebo-controlled Trial

Overview

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.

Detailed description

Non-alcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction-associated fatty liver disease (MAFLD), refers to a spectrum of conditions characterized by abnormal lipid metabolism leading to fat accumulation within the liver. This spectrum includes non-alcoholic fatty liver (NAFL), non-alcoholic steatohepatitis (NASH), hepatic fibrosis, and cirrhosis.

Linzhi Jianghuang Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) is composed of five herbs (e.g., Salviae Miltiorrhizae Radix et Rhizoma, Puerariae Lobatae Radix). A total of 180 participants aged 18-65 years with Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 10% will be recruited and randomized to receive either LJF or placebo in a 1:1 ratio for 24 weeks.

Interventions

• 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).
• Other Placebo
  The placebo contains caramel color, sucrose octaacetate, sucralose, etc.

Primary outcome measures

• MRI-PDFF [Time frame: Week-0, week-24.]

Secondary outcome measures (11)

• Liver fat content [Time frame: Week-0, week-12, and week-24.]
• Liver stiffness [Time frame: Week-0, week-12, and week-24.]
• Metabolic parameter [Time frame: Week-0, week-24.]
• Anthropometric parameter [Time frame: Week-0, week-12, and week-24.]
• Fatty Liver Index [Time frame: Week-0, week-24.]
• Hepatic Steatosis Index [Time frame: Week-0, week-24.]
• Fibrosis-4 Index [Time frame: Week-0, week-24.]
• CLDQ-NAFLD [Time frame: Week-0, week-12, and week-24.]
• Sleep quality [Time frame: Week-0, week-12, and week-24.]
• Fatigue [Time frame: Week-0, week-12, and week-24.]
• Adverse events [Time frame: From week-0 to week-24]

Eligibility criteria

Inclusion criteria

• 1\) Age between 18 and 65 years (inclusive);
• 2\) Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 10%;
• 3\) Liver stiffness measured by transient elastography < 7.3 kPa;
• 4\) Presence of one or more metabolic risk factors: a. Fasting plasma glucose ≥ 6.1 mmol/L, or 2-hour postprandial glucose ≥ 7.8 mmol/L, or HbA1c ≥ 5.7%, or a history of type 2 diabetes, or HOMA-IR ≥ 2.5; b. Arterial blood pressure ≥ 130/85 mmHg, or receiving antihypertensive medication; c. Fasting serum triglycerides ≥ 1.7 mmol/L;
• 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.
• 6\) Understand the trial content thoroughly and voluntarily sign the informed consent form.

Exclusion criteria

• 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;
• 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;
• 3\) Presence of severe concurrent diseases affecting the heart, brain, hematopoietic system, immune system, or kidneys (BUN > 1.5 × ULN, Cr > ULN);
• 4\) Presence of other endocrine system disorders, such as hyperthyroidism, Cushing's syndrome, etc.;
• 5\) History of malignancy that has not been in complete remission for more than 5 years;
• 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;
• 7\) Poorly controlled severe hypertension, defined as systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg;
• 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;
• 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;
• 10\) Current use or use within the past 3 months of GLP-1 receptor agonists;
• 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);
• 12\) Regular use of hepatoprotective drugs or vitamin E within the past month;
• 13\) History of bariatric surgery within the past year, or body weight change > 5% within the past 3 months;
• 14\) History of surgery within the past month;
• 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.);
• 16\) Concomitant psychiatric or psychological disorders, or substance/drug abuse;
• 17\) Known allergic constitution, or known allergy to any component of LJF;
• 18\) Participation in another clinical trial within the past month;
• 19\) Contraindications for MRI examination, such as claustrophobia or presence of metallic implants;
• 20\) Individuals of childbearing potential (male or female) with fertility plans; pregnant or lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07637006 · REC/25-26/0489

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗