Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver
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
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
Treatments tested in this trial
- Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF)
- Placebo
Treatment groups
180 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov