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Herbal capsule could shrink fatty liver in new trial

NCT ID NCT07637006

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a Chinese herbal capsule called Linzhi Jianghuang Fufang Huoxue Anshen (LJF) can safely reduce liver fat in people with non-alcoholic fatty liver disease. About 180 adults aged 18 to 65 with high liver fat will take the capsule or a placebo for 24 weeks. The main goal is to see if the capsule lowers liver fat measured by MRI.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

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