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

ConditionMetabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHong Kong Baptist University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Placebo

    Other intervention

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: LJF groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Week-0, week-24.

Secondary outcomes

1

Liver fat content

Changes in liver fat content from baseline, as measured by Liverscan.

Time frame
Week-0, week-12, and week-24.
2

Liver stiffness

Changes in liver stiffness from baseline, as measured by Liverscan.

Time frame
Week-0, week-12, and week-24.
3

Metabolic parameter

Changes in metabolic parameter (e.g., insulin resistance) from baseline to the end of 24 weeks of treatment.

Time frame
Week-0, week-24.
4

Anthropometric parameter

Changes in anthropometric parameter (e.g., Body Mass Index) from baseline.

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

Other outcomes

1

Dietary intake

Dietary intake will be assessed using a validated Food Frequency Questionnaire (FFQ).

Time frame
Week-0, week-12, and week-24.
2

Physical activity

Physical activity (e.g., step count) as measured by a smartwatch.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong Kong Baptist University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: