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Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD

NCT07085962 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Metabolic Dysfunction-associated Fatty Liver Disease

Interventions

DRUG

Calculus bovis sativus

Calculus bovis sativus 200mg qd

DRUG

Placebo

Placebo 200mg qd

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Bin Cheng, Doctor · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-03-31
Completion
2026-07-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085962 on ClinicalTrials.gov