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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) is composed of five herbs (e.g., Salviae Miltiorrhizae Radix et Rhizoma, Puerariae Lobatae Radix).
The placebo contains caramel color, sucrose octaacetate, sucralose, etc.
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.
Liver fat content
Changes in liver fat content from baseline, as measured by Liverscan.
Time frame: Week-0, week-12, and week-24.
Liver stiffness
Changes in liver stiffness from baseline, as measured by Liverscan.
Time frame: 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.
Time frame: Week-0, week-24.
Anthropometric parameter
Changes in anthropometric parameter (e.g., Body Mass Index) from baseline.
Time frame: 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.
Time frame: 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.
Time frame: Week-0, week-24.
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From week-0 to week-24