Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra
Dietary SupplementOral combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra
NCT Number: NCT06798948
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Select..., China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra
The patient takes two tablets of the placebo maltodextrin every day
Time frame: Baseline, up to 12 weeks of the study
Magnetic Resonance Imaging (MRI) technology utilizes magnetic fields and radiofrequency pulses to conduct non-invasive examinations of tissues. When measuring liver fat content, MRI employs water-fat separation techniques to quantify the proton density of water molecules and fat molecules (PDFF) within the liver, thereby providing a quantitative analysis of fat content.
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (γ-GT), alkaline phosphatase (ALP), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), alcohol dehydrogenase (ADH), aldehyde dehydrogenase (ALDH)
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
Hemoglobin A1c (HbA1c)
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
Fasting blood glucose
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
Serum triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein A-I (ApoA-I), apolipoprotein B (Apo B).
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
High-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
tumor necrosis factor (TNF-α)
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
interleukins (IL-1β, IL-6).
Time frame: Baseline, up to 12 weeks of the study
16s rRNA sequencing
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
Blood creatinine (CREA), urea nitrogen (BUN), uric acid (UA)
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
Blood routine examination indicators
Time frame: Baseline, up to 6 weeks, up to 12 weeks,up to 16 weeks of the study
Urinalysis examination indicators
Contact information is provided by the study sponsor or research team.
Kaixin Pan
CONTACT
Qingling Huang
CONTACT
Li Lab,MD
Other Gov
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