NCT07085962

Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD

A Randomized, Controlled Study to Evaluate the Efficacy and Safety of Calculus Bovis Sativus in Adult Subjects With Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed as a randomized, double-blind, placebo-controlled trial to investigate calculus bovis sativus in adult subjects with metabolic dysfunction-associated fatty liver disease (MAFLD). The study aims to evaluate the safety of calculus bovis sativus in subjects with MAFLD by monitoring the incidence of adverse events and key laboratory parameters, including routine blood and urine tests, as well as hepatic and renal function, and to preliminarily investigate the potential clinical efficacy of calculus bovis sativus in mitigating MAFLD, liver injury, and inflammation by monitoring various serum biomarkers and non-invasive assessment parameters, such as the controlled attenuation parameter (CAP), liver stiffness measurement (LSM), and magnetic resonance imaging proton density fat fraction (MRI-PDFF). Furthermore, this study will employ a multi-omics approach, combining metagenomics and metabolomics, to explore the effects of calculus bovis sativus on the gut microbiota and its metabolites in patients with MAFLD.

Conditions

• Metabolic Dysfunction-associated Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Calculus bovis sativus	Calculus bovis sativus 200mg qd
DRUG	Placebo	Placebo 200mg qd

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-03-31
• Completion: 2026-07-31
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: China