Effect of the Combined Application of Cynara Scolymus, Silybum Marianum, Curcuma Longa, and Glycyrrhiza Glabra in Improving Metabolic Associated Fatty Liver Disease : a Randomized Clinical Trial

Summary

Metabolic-associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by nutrient excess and insulin resistance (IR) in genetically susceptible individuals. With the prevalence of obesity and type 2 diabetes, the morbidity and incidence of MAFLD have been increasing globally, particularly in China. MAFLD and metabolic syndrome as well as type 2 diabetes are mutually causal, jointly promoting the incidence of atherosclerotic cardiovascular disease, chronic kidney disease, liver decompensation, and malignant tumors such as hepatocellular carcinoma. MAFLD has become an increasingly severe public health issue in China. Effective clinical interventions for MAFLD patients are of great public health significance for the prevention of terminal diseases.

Cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra are traditional Chinese medicinal herbs that have demonstrated significant effectiveness in improving metabolic diseases. Cynara scolymus contains polyphenols, flavonoids, terpenes, and other substances, possessing antioxidant, anti-aging, anti-tumor, anti-microbial, antihypertensive, and kidney-tonifying properties. Silybum marianum belongs to the Compositae family and has the effects of clearing heat and detoxifying, soothing the liver, and promoting bile flow. The active ingredient of silybum marianum is silymarin, a flavonoid compound, which has antioxidant and anti-hepatic fibrotic effects, protecting hepatocytes from damage by free radicals and promoting hepatocyte regeneration and repair. Curcuma longa is a flowering plant of the zingiberaceae family, and its active ingredient curcumin has multiple functional properties such as anti-tumor, anti-inflammatory, hypoglycemic, and antioxidant activities. Glycyrrhiza glabra is one of the commonly used medicinal plants, possessing the effects of clearing heat and detoxifying, tonifying the spleen and benefiting qi, nourishing the lungs, and resolving phlegm. Its main active ingredients include triterpenoid saponins, flavonoids, and polysaccharides, which exhibit various pharmacological effects such as antioxidant, immunoregulatory, antiviral, and anti-tumor activities. At the human population level, there is currently no research on the combined intervention of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra in patients with MAFLD.

Therefore, this study intends to conduct a randomized controlled double-blind trial to explore the effects of the combined application of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra on liver function, liver fat content, glucose and lipid metabolism, and other aspects in patients with MAFLD, in order to clarify the health improvement effects of this combined intervention in patients with MAFLD and provide population-based evidence and strategies for health promotion in this patient group.

Conditions

• Metabolic-associated Fatty Liver Disease (MAFLD)

Interventions

DIETARY_SUPPLEMENT

Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra

Oral combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra

OTHER

Placebo maltodextrin

The patient takes two tablets of the placebo maltodextrin every day

Sponsors & Collaborators

• Xin Hua Hospital of Zhejiang Province

  collaborator OTHER

• Li Lab,MD

  lead OTHER_GOV

Principal Investigators

• Songtao Li · Zhejiang Chinese Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations