Table 2.

Currently running and active clinical trials based on: https://clinicaltrials.gov.

Title	Status	Conditions	Interventions	Phase	Measures	Enrollment	Age (Years)	Completion:
A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients with Previous Colorectal Cancer	Recruiting	Colorectal Adenomas	Berberine hydrochloride and Placebo	Phase 2 Phase 3	Cumulative colorectal adenoma incidence rate during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer Cumulative numbers or diameters of new colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer	1000	18–80	March 2021
Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients	Recruiting	Schizophrenia Metabolic Syndrome	Berberine Metformin	Phase 4	Fasting blood samples for Fasting blood glucose Triglyceride High-Density Lipoprotein Waist circumference Blood pressure including systolic and diastolic pressure Body mass index Total Cholesterol C reactive protein Interleukin-1,Interleukin-6,tumor necrosis factor(TNF)	100	18–65	December 2019
Primary Chemoprevention of Familial Adenomatous Polyposis with Berberine Hydrochloride	Recruiting	Colorectal Adenomas	Berberine hydrochloride Placebo	Phase 2 Phase 3	Cumulative numbers and diameters of colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with familial adenomatous polyposis	100	18–65	December 2020
Effect of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes	Active, not recruiting	Prediabetes Impaired Fasting Glucose Impaired Glucose Tolerance	Berberine Metformin	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 and 8 more	28	31–60	August 2020
Effect of Berberine for Endothelial Function and Intestinal Microflora in Patients with Coronary Artery Disease	Active, not recruiting	Stable Coronary Artery Disease Percutaneous Coronary Intervention	Berberine Aspirin Clopidogrel Statin	Phase 1 Phase 2	Endothelial function measured by flow mediated dilation Gut microbiome Fecal metabolomics profile measurement Blood lipid levels Inflammatory factor levels Blood glucose levels	24	18–75	December 2020
A Mechanistic Randomized Controlled Trial on the Cardiovascular Effect of Berberine	Recruiting	Cardiovascular Risk Factor	Berberine Placebo	Phase 2 Phase 3	lipid profile blood pressure thromboxane A2 testosterone body mass index waist hip ratio fasting glucose fasting insulin liver function	84	20–65	June 2020
Combination of Danazole With Berberine in the Treatment of ITP	Active, not recruiting	Corticosteroid-resistant or Relapsed ITP	Berberine plus danazol	Phase 2	The Count of Participants That Achieved 6-month Sustained Response the Count of Participants That Had Adverse Events the Count of Participants That Achieved Initial Response	55	18–80	June 2021
Antiplatelet Effect of Berberine in Patients After Percutaneous Coronary Intervention	Recruiting	Coronary Artery Disease Percutaneous Coronary Intervention	Berberine Standard treatment Aspirin Clopidogrel	Phase 4	P2Y12 reaction unit Platelet reactivity index Urinary 11-dehydrothromboxane B2 (11-dHTXB2)	64	18–70	December 2020
Berberine Chloride in Preventing Colorectal Cancer in Patients with Ulcerative Colitis in Remission	Active, not recruiting	Ulcerative Colitis	Berberine Chloride Placebo	Phase 1	Incidence of organ toxicity Clinical efficacy of berberine chloride measured using the UCDAI score plasma markers of inflammation colorectal tissue biomarkers expression gene methylation status blood berberine chloride concentration Severity of histologic inflammation	18	18–70	December 2020
Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes	Recruiting	Diabetes Mellitus Chronic Kidney Disease	Berberine	Phase 4	Contrast-induced nephropathy Major adverse renal events	800	18 and older	December 2020
Berberine as Adjuvant Treatment for Schizophrenia Patients	Recruiting	Schizophrenia Spectrum and Other Psychotic Disorders Metabolic Syndrome x	Berberine Placebos Antipsychotic Agents	Phase 2 Phase 3	Weight gain Changes in body mass index Changes in waist circumference Changes in blood pressure Changes in triglycerides Changes in total cholesterol Changes in high-density lipoprotein Changes in low-density lipoprotein Changes in fasting glucose Changes in insulin	120	18–65	May 2021
Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study	Recruiting	Metabolic Syndrome	Berberine Identical Placebo	Not Applicable	LDL Cholesterol Hemoglobin A1c Number of participants with adverse events	40	18 and older	December 2021
Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis	Recruiting	Non-alcoholic Steatohepatitis	Behavioral: Lifestyle Placebo	Phase 4	Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning Improvement in liver histological fibrosis staging Resolution of NASH anthropometric measures blood biochemistry liver fat content serum cytokeratin 18 (CK-18) in U/L	120	18–75	July 2021
Study on the Efficacy and Gut Microbiota of Berberine and Probiotics in Patients with Newly Diagnosed Type 2 Diabetes	Active, not recruiting	Type 2 Diabetes	Berberine hydrochloride ProMetS probiotics powder	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 Serum LDL-c	400	20–69	May 2019
Effect of Mebo Dressing Versus Standard Care on Managing Donor and Recipient Sites of Split-thickness Skin Graft	Recruiting	Burns	Moist Exposed Burn Ointment (MEBO-sesame oil, beta-sitosterol, berberine and other small quantities of plant ingredients)	Phase 1	Wound Healing Assessment Recovery Time Rate of Infections Pain Assessment Total Treatment Costs Rate of Complications Quality of Life	40	2–60	July 2019