Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuazhong University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Calculus bovis sativus
DrugCalculus bovis sativus 200mg qd
Placebo
DrugPlacebo 200mg qd
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Calculus bovis sativus groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Alanine Aminotransferase (ALT) at Week 12
Alanine Aminotransferase (ALT) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Time frame
At baseline and after 4 weeks,8 weeks and 12 weeks of treatmentSecondary outcomes
1
Change from Baseline in Aspartate Aminotransferase (AST) at Week 12
Aspartate Aminotransferase (AST) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Time frame
Baseline, Week 4, Week 8, and Week 122
Change from Baseline in Gamma-glutamyl Transferase (GGT) at Week 12
Gamma-glutamyl Transferase (GGT) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Time frame
At baseline and after 4 weeks,8 weeks and 12 weeks of treatment3
Change from Baseline in Total Bilirubin at Week 12
Total Bilirubin will be measured from serum samples. The result will be reported in micromoles per liter (μmol/L).
Time frame
At baseline and after 4 weeks,8 weeks and 12 weeks of treatment4
Change from Baseline in Alkaline Phosphatase (ALP) at Week 12
Alkaline Phosphatase (ALP) will be measured from serum samples. The result will be reported in international units per liter (U/L).
Time frame
At baseline and after 4 weeks,8 weeks and 12 weeks of treatmentSponsors and contacts
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Source ClinicalTrials.gov
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