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New treatment option for Metabolic-associated Fatty Liver Disease (MAFLD)
Official title 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
ClinicalTrials.gov ID: NCT06798948
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people who meet the clinical diagnostic criteria for metabolic-associated fatty liver disease and have mild to moderate fatty liver.
- Aged 18-65, regardless of gender.
- Have not taken any liver-protecting medications in the past 3 months.
- Informed people who voluntarily sign the informed consent form and agree to participate in all visits and treatments as required by the trial...
You likely can't join if
- Excessive alcohol consumption or inability to quantify alcohol consumption within the past 12 months (weekly ethanol intake: ≥210g for males, ≥140g...
- Currently pregnant and/or lactating women, or women planning to become pregnant within the next 3 months.
- Diagnosed with allergies or other known or suspected allergic reactions (systemic, inhaled, or localized), with a history of sensitivity to...
- Previous or current use of liver-protecting products containing ingredients such as cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza...
- Coexisting with other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, cirrhosis, drug-induced liver...
- Diagnosed with obesity, hypertension, and/or diabetes and taking relevant therapeutic drugs (e.g., orlistat for obesity treatment, statins for...
See the full eligibility criteria
- people who meet the clinical diagnostic criteria for metabolic-associated fatty liver disease and have mild to moderate fatty liver.
- Aged 18-65, regardless of gender.
- Have not taken any liver-protecting medications in the past 3 months.
- Informed people who voluntarily sign the informed consent form and agree to participate in all visits and treatments as required by the trial protocol.
- Excessive alcohol consumption or inability to quantify alcohol consumption within the past 12 months (weekly ethanol intake: ≥210g for males, ≥140g for females).
- Currently pregnant and/or lactating women, or women planning to become pregnant within the next 3 months.
- Diagnosed with allergies or other known or suspected allergic reactions (systemic, inhaled, or localized), with a history of sensitivity to ingredients in the product formula.
- Previous or current use of liver-protecting products containing ingredients such as cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra , etc.
- Coexisting with other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, cirrhosis, drug-induced liver disease, Wilson's disease, etc.
- Diagnosed with obesity, hypertension, and/or diabetes and taking relevant therapeutic drugs (e.g., orlistat for obesity treatment, statins for lipid-lowering, hydrochlorothiazide, metoprolol, bisoprolol for hypertension...
- Coexisting with specific diseases that can lead to fatty liver, such as total parenteral nutrition, abetalipoproteinemia, congenital lipoatrophic diabetes, celiac disease, etc.
- Long-term use of drugs known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.).
- Coexisting with severe cardiovascular and cerebrovascular diseases or renal insufficiency.
- Unstable weight and metabolic parameters within 6 to 8 weeks before randomization, with weight changes exceeding 5% or rapid weight loss (\>1.6 kg/week).
- History of malignancy within the past five years (except for localized skin basal cell carcinoma), regardless of recurrence or metastasis.
- History of immunosuppression or immunodeficiency disorders (including HIV or AIDS), or current use of immunosuppressive drugs or radiotherapy.
- Chronic diseases and endocrine disorders such as asthma, epilepsy, hyperthyroidism or hypothyroidism, and/or the use of corresponding therapeutic drugs.
- History of drug abuse.
- History of antibiotic use within the past month.
- Participation in other population intervention studies within the past 3 months or receipt of other non-study group treatments during the study.
- Other conditions or diseases that, in the judgment of other researchers, may reduce the likelihood of enrollment or complicate the enrollment process, such as frequent changes in work environment, unstable living...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Select..., China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Select..., China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.