Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)Phase 2LJFNCT07637006
Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver
A Phase 2 study testing Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) in people with Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), run by Hong Kong Baptist University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
- What is being tested?
- Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF), Placebo
- 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
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
PlaceboOther
The placebo contains caramel color, sucrose octaacetate, sucralose, etc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week-0, week-24.
Secondary outcomes (11)
Liver fat content
Changes in liver fat content from baseline, as measured by Liverscan.
Measured: Week-0, week-12, and week-24.
Liver stiffness
Changes in liver stiffness from baseline, as measured by Liverscan.
Measured: 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.
Measured: Week-0, week-24.
Anthropometric parameter
Changes in anthropometric parameter (e.g., Body Mass Index) from baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From week-0 to week-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637006
- Sponsor's protocol ID
- REC/25-26/0489
- Acronym
- LJF
- Status last verified
- Mar 2026
- First submitted
- 28 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07637006
- Acronym / sponsor ID
- LJF / REC/25-26/0489
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LJF group | Experimental | Drug: Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF)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. |
| Placebo group | Placebo comparator | Other: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | LJF group |
| PlaceboThe placebo contains caramel color, sucrose octaacetate, sucralose, etc. | Other | Placebo group |
Primary outcome
MRI-PDFF
Time frame: Week-0, week-24.
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) in people with Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), run by Hong Kong Baptist University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jialing ZHANG, PhD (852-34115024, zhangjialing@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-PDFF (time frame: Week-0, week-24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.