Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD

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.

NCT Number	NCT07085962
Lead Sponsor	Huazhong University of Science and Technology
Conditions	Metabolic Dysfunction-associated Fatty Liver Disease
Enrollment	40 participants
Start Date	2025-08-01
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-25