Table 2.

Active clinical trials with berberine on the metabolic syndrome and its corresponding diseases based on clinicaltrials.gov (accessed on 10 Fabruary 2022).

Title	Conditions	Status	Phase	Measures
A Research of berberine hydrochloride to prevent colorectal adenomas in patients with previous colorectal cancer	Colorectal adenomas	Recruiting	Phase 2 Phase 3	Cumulative colorectal adenoma Cumulative numbers or diameters of new colorectal adenomas
Comparison of berberine and metformin for the treatment of MS in schizophrenia patients	Schizophrenia Metabolic syndrome	Recruiting	Phase 4	Fasting blood glucose Triglyceride High-density lipoprotein Waist circumference Blood pressure including systolic and diastolic pressure Body mass index Total cholesterol CRP Interleukin-1, interleukin-6, TNF-α
Effect of berberine versus metformin on glycemic control, insulin sensitivity, and insulin secretion in prediabetes	Prediabetes impaired Fasting glucose impaired Glucose tolerance	Active, not recruiting	Phase 4	Fasting glucose levels Postprandial glucose levels Glycosylated hemoglobin Total insulin secretion First phase of insulin secretion Insulin sensitivity Body weight Body mass index Body fat percentage Waist circumference
Effect of berberine for endothelial function and intestinal microflora in patients with coronary artery disease	Stable coronaryartery diseasePercutaneous coronary intervention	Active, not recruiting	Phase 1 Phase 2	Endothelial function Gut microbiome Fecal metabolomics profile Blood lipid levels Inflammatory factor levels Blood glucose levels
Berberine prevents contrast-induced nephropathy in patients with diabetes	Diabetes mellitus Chronic kidney disease	Recruiting	Phase 4	Contrast-induced nephropathy Major adverse renal events
Berberine as adjuvant treatment for schizophrenia patients	Schizophrenia Schizophrenia spectrum and other psychotic disorders Metabolic syndrome X	Recruiting	Phase 2 Phase 3	Weight gain Body mass index Waist circumference Blood pressure Triglycerides Total cholesterol High-density lipoprotein Low-density lipoprotein Fasting glucose Insulin
Evaluating the tolerability and effects of berberine on major metabolic biomarkers: a pilot study	Metabolic syndrome	Recruiting	Not Applicable	LDL cholesterol Hemoglobin A1c Adverse events
Efficacy and safety of berberine in non-alcoholic steatohepatitis	Non-alcoholic steatohepatitis	Recruiting	Phase 4	Histologic features of non-alcoholic steatohepatitis Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, and hepatocellular ballooning Improvement in liver histological fibrosis staging Anthropometric measures Blood biochemistry Liver fat content Serum cytokeratin 18
Study on the efficacy and gut microbiota of berberine and probiotics in patients with newly diagnosed type 2 diabetes	Type 2 diabetes	Active, not recruiting	Phase 3	HbA1c Gut microbiome Fasting glucose levels 2-h postprandial glucose levels Fasting insulin levels 2-h postprandial insulin levels Serum triglycerides Serum total cholesterol Serum HDL-C
Effect of berberine hydrochloride on blood pressure and vascular endothelial function in patients With hypertension	Hypertension Endothelial dysfunction Blood pressure	Recruting	Phase 4	Blood pressure Brachial ankle pulse wave velocity Blood pressure Brachial arterial flow-mediated dilation
Effect of berberine on metabolic syndrome, efficacy and safety in combination with antiretroviral therapy in PLWH	Metabolic syndrome HIV-1-infection Glucose intolerance	Not yet recruiting	Phase 3	Insulin resistance Measurement of total cholesterol, HDL, LDL, triglycerides Weight gain or loss measured by kilograms Level of pro-inflammatory cytokines
Berberine prevents contrast-induced nephropathy in patients with diabetes	Diabetes mellitus Chronic kidney disease	Recruiting	Phase 4	Contrast-induced nephropathy Increase in serum creatinine Major adverse renal events
Evaluating the tolerability and effects of berberine on major metabolic biomarkers: a pilot study	Metabolic syndrome	Recruiting	Not Applicable	Change in LDL Cholesterol Change in Hemoglobin A1c Adverse events
Efficacy and safety of berberine in non-alcoholic steatohepatitis	Non-alcoholic steatohepatitis	Recruiting	Phase 4	Histologic features of non-alcoholic steatohepatitis Liver histological fibrosis staging BMI Blood biochemistry Liver fat content Serum cytokeratin 18
Study to determine the effect of synbiotics in patients with pre-diabetes	Pre-diabetes	Recruiting	Not Applicable	Blood glucose levels Metabolic impact of metabolic rheostat and butyrate ultra Gut hormones/incretins (including insulin, C-peptide, glucagon, CCK, GLP-1, GIP, and PYY) Impact of metabolic rheostat and butyrate ultra on food addiction and cravings