Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD (NCT07085962) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD
China40 participantsStarted 2025-08-01
Plain-language summary
Metabolic dysfunction-associated fatty liver disease (MAFLD) has become the most common chronic liver disease worldwide. Timely therapeutic intervention for MAFLD is crucial for improving patient prognosis and preventing its progression to liver fibrosis, cirrhosis, and even hepatocellular carcinoma (HCC). Therefore, the discovery of novel drugs for the treatment of MAFLD is of great significance.
Previous clinical studies have shown that calculus bovis sativus, as an adjuvant therapy for icteric hepatitis and chronic hepatitis B, exhibits significant anti-inflammatory and enzyme-reducing effects, improves liver function indicators, and enhances overall clinical outcomes. However, there is currently no clinical research on the therapeutic effects of calculus bovis sativus in patients with MAFLD, and its underlying mechanisms of action remain to be elucidated.
This study proposes a randomized, double-blind, placebo-controlled trial to investigate the effects of calculus bovis sativus in adult patients with MAFLD. The primary objective is to preliminarily explore the clinical efficacy of calculus bovis sativus in treating MAFLD, particularly its impact on liver injury and inflammation. Furthermore, this research will employ a multi-omics approach, integrating metagenomics and metabolomics, to analyze the effects of calculus bovis sativus on the gut microbiota and their metabolites in MAFLD patients. The aim is to uncover its potential mechanisms of action, thereby facilitating its clinical translation and application, and ultimately providing a new therapeutic strategy for patients with MAFLD.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Has signed the informed consent form (ICF) prior to the study and is fully aware of the study's content, procedures, and potential adverse reactions.
✓. Is able to complete the study in accordance with the protocol requirements.
✓. The subject (and/or partner) agrees to use effective contraceptive measures voluntarily from the screening period until 6 months after the last dose of the investigational product.
✓. At the time of signing the ICF, age is between 18 and 75 years (inclusive), with no restriction on sex.
✓. Meets the diagnostic criteria outlined in the "Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Non-alcoholic) Fatty Liver Disease (2024 Edition)" issued by the Chinese Society of Hepatology, Chinese Medical Association.
✓. Confirmed significant hepatic steatosis by transient elastography (Fibroscan) with a Controlled Attenuation Parameter (CAP) value ≥ 240 dB/m.
✓. Liver enzyme levels meet the following criteria: 1 × upper limit of normal (ULN) \< serum AST and ALT \< 5 × ULN.
Exclusion criteria
What they're measuring
1
Change from Baseline in Alanine Aminotransferase (ALT) at Week 12
Timeframe: At baseline and after 4 weeks,8 weeks and 12 weeks of treatment
Trial details
NCT IDNCT07085962
SponsorHuazhong University of Science and Technology
✕. Stable body weight for at least 6 weeks prior to screening, defined as a weight change (increase or decrease) of ≤5%.
✕. Presence of the following chronic diseases: viral hepatitis; positive serology for Human Immunodeficiency Virus (HIV); primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, drug-induced liver disease, alcoholic liver disease, or Wilson's disease.
✕. Excessive alcohol consumption (defined as \>30g of alcohol per day for males or \>20g per day for females).
✕. History of diabetes other than type 2 diabetes, such as type 1 diabetes, secondary diabetes, etc.
✕. History of malignancy (except for those with a tumor-free period of more than 5 years prior to screening), or currently under evaluation for active or suspected malignancy. Exceptions include fully treated basal cell carcinoma, squamous cell skin carcinoma, or cervical carcinoma in situ.
✕. History of bariatric surgery within the 5 years prior to screening (inclusive).
✕. Use of antibiotics within the last 3 weeks or during the study period.
✕. Underwent major surgery within 3 months prior to signing the ICF, or planning to undergo major surgery during the study period. (Major surgery is defined as a procedure with risk to the patient's life, particularly surgery involving the cranium, chest, abdomen, or pelvic organs).