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

NCT07637006 | Not Yet Recruiting Phase 2

• 1 other identifier: REC/25-26/0489
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)

Keywords

Non-alcoholic fatty liver; Traditional Chinese medicine; Non-alcoholic fatty liver disease; Metabolic dysfunction-associated fatty liver disease; Linzhi Jianghuang Fufang Huoxue Anshen Capsule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Liver fat content

  Week-0, week-12, and week-24.

• Liver stiffness

  Week-0, week-12, and week-24.

• Metabolic parameter

  Week-0, week-24.

• Anthropometric parameter

  Week-0, week-12, and week-24.

• Fatty Liver Index

  Week-0, week-24.

Other Outcomes (2)

• Dietary intake

  Week-0, week-12, and week-24.

• Physical activity

  Week-0, week-12, and week-24.

Study Arms (2)

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.

Drug: Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF)

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.

Other: Placebo

Interventions

Placebo OTHER

The placebo contains caramel color, sucrose octaacetate, sucralose, etc.

Placebo group

Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) DRUG

Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) is composed of five herbs (e.g., Salviae Miltiorrhizae Radix et Rhizoma, Puerariae Lobatae Radix).

LJF group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age between 18 and 65 years (inclusive);
• \) Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 10%;
• \) Liver stiffness measured by transient elastography \< 7.3 kPa;
• \) 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;
• \) 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.
• \) Understand the trial content thoroughly and voluntarily sign the informed consent form.

You may not qualify if:

• \) 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;
• \) 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;
• \) Presence of severe concurrent diseases affecting the heart, brain, hematopoietic system, immune system, or kidneys (BUN \> 1.5 × ULN, Cr \> ULN);
• \) Presence of other endocrine system disorders, such as hyperthyroidism, Cushing's syndrome, etc.;
• \) History of malignancy that has not been in complete remission for more than 5 years;
• \) 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;
• \) Poorly controlled severe hypertension, defined as systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg;
• \) 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;
• \) 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;
• \) Current use or use within the past 3 months of GLP-1 receptor agonists;
• \) Adjustment of hypoglycemic, antihypertensive, or lipid-lowering medications within the past 3 months (e.g., adding or discontinuing medication, dose change, or irregular use);
• \) Regular use of hepatoprotective drugs or vitamin E within the past month;
• \) History of bariatric surgery within the past year, or body weight change \> 5% within the past 3 months;
• \) History of surgery within the past month;
• \) Coagulation abnormalities, or current use of medications or foods with anticoagulant effects (e.g., aspirin, warfarin, Panax notoginseng, safflower, Angelica sinensis, peach kernel, etc.);

Sponsors & Collaborators

• Hong Kong Baptist University: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Jialing ZHANG, PhD

CONTACT

852-34115024; zhangjialing@hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, assessors, and statistician will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-03