Using traditional herbs to improve fatty liver disease

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

This study is testing if a mix of traditional Chinese herbs can help people with fatty liver disease feel better and improve their liver health.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Zhejiang Chinese Medical University (other gov)
• Drugs / interventions: methotrexate
• Locations: 2 sites (Hangzhou, Select... and 1 other locations)
• Trial ID: NCT06798948 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a combination of traditional Chinese medicinal herbs, including Cynara scolymus, Silybum marianum, Curcuma longa, and Glycyrrhiza glabra, on patients with metabolic-associated fatty liver disease (MAFLD). The study aims to determine the efficacy of these herbs in improving liver health and metabolic function in individuals diagnosed with mild to moderate fatty liver. Participants will be randomly assigned to receive either the herbal combination or a placebo, with outcomes assessed through clinical evaluations and imaging techniques. The trial is particularly relevant given the rising prevalence of MAFLD in China, linked to obesity and type 2 diabetes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who have been diagnosed with mild to moderate metabolic-associated fatty liver disease and have not taken liver-protecting medications in the past three months.

Not a fit: Patients with excessive alcohol consumption, pregnant or lactating women, and those with known allergies to the study's herbal ingredients may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel herbal treatment option for patients suffering from metabolic-associated fatty liver disease.

How similar studies have performed: While the use of traditional herbs for metabolic conditions has been explored, this specific combination and its application for MAFLD is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Subjects who meet the clinical diagnostic criteria for metabolic-associated fatty liver disease and have mild to moderate fatty liver.
2. Aged 18-65, regardless of gender.
3. Have not taken any liver-protecting medications in the past 3 months.
4. Informed subjects who voluntarily sign the informed consent form and agree to participate in all visits and treatments as required by the trial protocol.

Exclusion Criteria:

1. Excessive alcohol consumption or inability to quantify alcohol consumption within the past 12 months (weekly ethanol intake: ≥210g for males, ≥140g for females).
2. Currently pregnant and/or lactating women, or women planning to become pregnant within the next 3 months.
3. 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.
4. Previous or current use of liver-protecting products containing ingredients such as cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra , etc.
5. Coexisting with other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, cirrhosis, drug-induced liver disease, Wilson's disease, etc.
6. 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 treatment, metformin, dapagliflozin for diabetes treatment, etc.).
7. Coexisting with specific diseases that can lead to fatty liver, such as total parenteral nutrition, abetalipoproteinemia, congenital lipoatrophic diabetes, celiac disease, etc.
8. Long-term use of drugs known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.).
9. Coexisting with severe cardiovascular and cerebrovascular diseases or renal insufficiency.
10. 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).
11. History of malignancy within the past five years (except for localized skin basal cell carcinoma), regardless of recurrence or metastasis.
12. History of immunosuppression or immunodeficiency disorders (including HIV or AIDS), or current use of immunosuppressive drugs or radiotherapy.
13. Chronic diseases and endocrine disorders such as asthma, epilepsy, hyperthyroidism or hypothyroidism, and/or the use of corresponding therapeutic drugs.
14. History of drug abuse.
15. History of antibiotic use within the past month.
16. Participation in other population intervention studies within the past 3 months or receipt of other non-study group treatments during the study.
17. 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 environment, etc., which may lead to loss to follow-up; inconvenience in daily living, etc.

Where this trial is running

Hangzhou, Select... and 1 other locations

• The Second Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Select..., China (RECRUITING)
• Zhejiang Xinhua Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Qingling Huang

Conditions: Metabolic-associated Fatty Liver Disease, Metabolic-associated fatty liver disease, MRI-PDFF, Chinese Medcine