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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
• Intervention / Treatment: Drug: Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF); Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jialing ZHANG, PhD; Phone Number: 852-34115024; Email: zhangjialing@hkbu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LJF group; 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.	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).
Placebo Comparator: Placebo group; 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.	Other: Placebo; The placebo contains caramel color, sucrose octaacetate, sucralose, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI-PDFF	Primary endpoint will be the change in liver fat content from baseline, as measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) after 24 weeks of treatment.	Week-0, week-24.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver fat content	Changes in liver fat content from baseline, as measured by Liverscan.	Week-0, week-12, and week-24.
Liver stiffness	Changes in liver stiffness from baseline, as measured by Liverscan.	Week-0, week-12, and week-24.
Metabolic parameter	Changes in metabolic parameter (e.g., insulin resistance) from baseline to the end of 24 weeks of treatment.	Week-0, week-24.
Anthropometric parameter	Changes in anthropometric parameter (e.g., Body Mass Index) from baseline.	Week-0, week-12, and week-24.
Fatty Liver Index	Change in Fatty Liver Index (FLI) score from baseline to the end of 24 weeks of treatment. It ranges from 0 to 100. A FLI < 30 can be used to rule out and a FLI ≥ 60 to rule in hepatic steatosis.	Week-0, week-24.
Hepatic Steatosis Index	Change in Hepatic Steatosis Index (HSI) score from baseline to the end of 24 weeks of treatment. The result is expressed on a scale from 0 to 100, with values <30 ruling out fatty liver, whereas values >36 confirm its presence.	Week-0, week-24.
Fibrosis-4 Index	Change in Fibrosis-4 Index (FIB-4) score from baseline to the end of 24 weeks of treatment. A FIB-4 score below 1.30 generally indicates a low likelihood of liver fibrosis.	Week-0, week-24.
CLDQ-NAFLD	Changes in the Chronic Liver Disease Questionnaire-Non-Alcoholic Fatty Liver Disease (CLDQ-NAFLD) score. Each item is scored on a 7-point Likert scale, and the total score is the average of the 6 domain scores, with higher scores indicating better quality of life.	Week-0, week-12, and week-24.
Sleep quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item instrument whose items generate 7 component scores that are summed into a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.	Week-0, week-12, and week-24.
Fatigue	Fatigue will be assessed using the Chalder Fatigue Questionnaire (CFQ-11), an 11-item instrument whose scores are summed into a total score ranging from 0 to 33, with higher scores indicating greater fatigue.	Week-0, week-12, and week-24.
Adverse events	Adverse events (AEs) occurring from the participant's enrollment to the end of the trial and any abnormal changes in laboratory parameters will be recorded.	From week-0 to week-24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake	Dietary intake will be assessed using a validated Food Frequency Questionnaire (FFQ).	Week-0, week-12, and week-24.
Physical activity	Physical activity (e.g., step count) as measured by a smartwatch.	Week-0, week-12, and week-24.

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Non-alcoholic fatty liver disease; Traditional Chinese medicine; Non-alcoholic fatty liver; Metabolic dysfunction-associated fatty liver disease; Linzhi Jianghuang Fufang Huoxue Anshen Capsule
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: REC/25-26/0489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No