Clinical Trials

Numerous clinical trials evaluate the therapeutic potential and pharmacokinetic profile of berberine across conditions including metabolic syndrome, polycystic ovary syndrome, Helicobacter pylori infection, chronic gastritis, pre-diabetes, and colorectal adenomas, as well as in healthy volunteers. Spanning Early Phase 1 through Phase 4, these studies are sponsored by various academic and medical institutions, such as University Medicine Greifswald and Xijing Hospital of Digestive Diseases. Their recruitment statuses encompass a wide range, from actively recruiting and enrolling by invitation to completed and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07541898 NOT_YET_RECRUITING
Cardiometabolic Syndrome
University of Central Lancashire
 2026-07-01
NCT07440147 RECRUITING
Obesity & Overweight; Circadian Rhythm Disorders; Gut Microbiota Modulation; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
FH Joanneum Gesellschaft mbH
 2026-01-20
NCT07465575 NOT_YET_RECRUITING
Polycystic Ovary Syndrome
Liaquat University of Medical & Health Sciences
 2026-03-16
NCT05749874 ACTIVE_NOT_RECRUITING
PreDiabetes; Abdominal Obesity; Hypertension; Dyslipidemias; Atherosclerotic Cardiovascular Disease
China National Center for Cardiovascular Diseases
 2023-10-31 PHASE4
NCT07129460 NOT_YET_RECRUITING
Gastric Intestinal Metaplasia
Xijing Hospital of Digestive Diseases
 2025-10-01 PHASE4
NCT05105321 NOT_YET_RECRUITING
Metabolic Syndrome
Tang Yida
 2021-12 PHASE4
NCT07180563 RECRUITING
Chronic Endometritis
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
 2025-03-15 PHASE1; PHASE2
NCT07420231 RECRUITING
Intestinal Discomfort; Abdominal Pain/ Discomfort
Université Catholique de Louvain
 2026-03-16
NCT07519681 NOT_YET_RECRUITING
Colorectal Adenomas; Colorectal Cancers
Jing-yuan Fang, MD, Ph. D
 2026-05-15
NCT07306988 RECRUITING
HELICOBACTER PYLORI INFECTIONS; Metabolic Syndrome
Nanjing First Hospital, Nanjing Medical University
 2025-04-17 PHASE4
NCT03378934 RECRUITING
Coronary Artery Disease; Percutaneous Coronary Intervention
Peking Union Medical College Hospital
 2018-09-26 PHASE4
NCT07480018 COMPLETED
Berberine; Sprint Training; Wellbeing; Anaerobic Power; Inflammation Biomarkers; Monocyte Function
University of Northern Colorado
 2026-01-01
NCT07359209 COMPLETED
Schizophrenia Therapeutics
Tianjin Anding Hospital
 2023-07-21
NCT07356765 ENROLLING_BY_INVITATION
Schizophrenia; Negative Symptoms of Schizophrenia
Tianjin Anding Hospital
 2023-09-26
NCT06911983 NOT_YET_RECRUITING
Diabetes Mellitis
S.LAB (SOLOWAYS)
 2025-07-01
NCT04698330 NOT_YET_RECRUITING
Type 1 Diabetes Mellitus; Autoimmune Diabetes
Second Xiangya Hospital of Central South University
 2022-05 PHASE4
NCT06782646 ENROLLING_BY_INVITATION
Hyperlipidemia
The University of Hong Kong
 2024-08-01 PHASE2; PHASE3
NCT04918667 NOT_YET_RECRUITING
Drug Absorption
EuroPharma, Inc.
 2024-09 PHASE1
NCT05720299 COMPLETED
Prediabetes
Yu Chen
 2025-03-12
NCT06700915 RECRUITING
Metabolism Disorder; Nutraceutical
Ultimate International, Inc.
 2024-10-03
NCT06514274 COMPLETED
Helicobacter Pylori Infection; Chronic Gastritis
Xijing Hospital of Digestive Diseases
 2024-09-20 PHASE4
NCT03976336 COMPLETED
Metabolic Syndrome
University of Kansas Medical Center
 2019-08-20
NCT06603688 UNKNOWN
Helicobacter Pylori Infection; Chronic Gastritis
Xijing Hospital of Digestive Diseases
 2023-11-20 PHASE4
NCT05596214 UNKNOWN
Diverticulitis
Dr. Adi Lahat
 2022-08-14 PHASE2
NCT06732908 COMPLETED
Safety
Isura
 2024-05-27
NCT06863922 COMPLETED
Diabetes Mellitus
S.LAB (SOLOWAYS)
 2024-05-03
NCT05647915 COMPLETED
Obesity; Obesity, Abdominal; NAFLD
China National Center for Cardiovascular Diseases
 2023-07-06 PHASE4
NCT06348550 UNKNOWN
Dyslipidemias; Dysglycemia
University of Pavia
 2023-11-30
NCT06273241 COMPLETED
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2024-03-04
NCT06273241 Not yet recruiting
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2024-03-04 Not Applicable
NCT06340308 UNKNOWN
Dyslipidemias
University of Pavia
 2023-06-07
NCT06202157 COMPLETED
Phase I and Phase II Metabolites of Berberine
Factors Group of Nutritional Companies Inc.
 2023-04-01
NCT05845931 COMPLETED
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2023-05-05
NCT05523024 UNKNOWN
Non Alcoholic Fatty Liver; Obesity
Poznan University of Medical Sciences
 2022-08-02
NCT03198572 UNKNOWN
Non-alcoholic Steatohepatitis
Fudan University
 2017-08-16 PHASE4
NCT04543643 UNKNOWN
Cirrhosis Due to Hepatitis B; Cirrhosis Due to Hepatitis C; Gastroesophageal Varices
Tianjin Second People's Hospital
 2021-11-01 PHASE3
NCT03708549 UNKNOWN
Schizophrenia; Metabolic Syndrome; Berberine; Metformin
Tianjin Anding Hospital
 2021-12-01 PHASE4
NCT05845931 Recruiting
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2023-05-05 Not Applicable
NCT05947370 COMPLETED
Diabetes Mellitus
Beijing Tongren Hospital
 2022-10-12 EARLY_PHASE1
NCT05602324 UNKNOWN
Severe Infection
University of British Columbia
 2021-10-01
NCT05480670 COMPLETED
Polycystic Ovary Syndrome
Ayub Teaching Hospital
 2022-11-01
NCT05570357 COMPLETED
Diabetes
National Nutrition and Food Technology Institute
 2022-07-01
NCT05463003 COMPLETED
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2022-07-19
NCT05480670 Completed
Polycystic Ovary Syndrome
Ayub Teaching Hospital
 2022-11-01 Not Applicable
NCT05463003 Completed
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2022-07-19 Not Applicable
NCT05370261 COMPLETED
Pharmacokinetics
Factors Group of Nutritional Companies Inc.
 2022-02-01
NCT04860063 UNKNOWN
Metabolic Syndrome; HIV-1-infection; Glucose Intolerance; Dyslipidemias; Lipodystrophy; Lipoatrophy
Hospital Civil de Guadalajara
 2021-04 PHASE3
NCT05014334 COMPLETED
Helicobacter Pylori Infection; Chronic Gastritis
Xijing Hospital of Digestive Diseases
 2021-12-01 PHASE4
NCT04790942 UNKNOWN
Hypertension; Endothelial Dysfunction; Blood Pressure
Jun Tao
 2020-10-22 PHASE4
NCT04697186 COMPLETED
Dyspepsia; Chronic Gastritis; Gastric Cancer; Helicobacter Pylori Infection
Xijing Hospital of Digestive Diseases
 2021-01-07 PHASE4
NCT02808351 COMPLETED
Diabetes Mellitus; Chronic Kidney Disease
Nanjing First Hospital, Nanjing Medical University
 2016-07 PHASE4
NCT02983188 COMPLETED
Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Metabolic Syndrome x
The University of Hong Kong
 2018-04-25 PHASE2; PHASE3
NCT03909763 UNKNOWN
Corticosteroid-resistant or Relapsed ITP
Peking University People's Hospital
 2016-01-20 PHASE2
NCT05021341 COMPLETED
Glycemia
Lindenwood University
 2020-06-22
NCT03770325 COMPLETED
Cardiovascular Risk Factor
The University of Hong Kong
 2019-04-01 PHASE2; PHASE3
NCT03281096 COMPLETED
Colorectal Adenomas
Xijing Hospital of Digestive Diseases
 2017-08-29 PHASE2; PHASE3
NCT04932070 COMPLETED
Polycystic Ovary Syndrome; Berberine
Azienda di Servizi alla Persona di Pavia
 2020-09-05
NCT03438292 COMPLETED
Healthy
University of Florida
 2018-09-25
NCT03333265 COMPLETED
Colorectal Adenomas
Xijing Hospital of Digestive Diseases
 2017-09-01 PHASE2; PHASE3
NCT05031715 UNKNOWN
Glucose Metabolism Disorders
Azienda di Servizi alla Persona di Pavia
 2020-03-02
NCT04479202 COMPLETED
Berberine; COVID-19
Chinese Medical Association
 2020-02-08 PHASE4
NCT02548832 COMPLETED
Mixed Dyslipidemia
University of Guadalajara
 2013-04 PHASE3
NCT03972215 COMPLETED
Diabetes Mellitus
Jin-Kui Yang
 2019-10-01 EARLY_PHASE1
NCT04434365 UNKNOWN
Stable Coronary Artery Disease; Percutaneous Coronary Intervention
Peking Union Medical College Hospital
 2019-06-21 PHASE1; PHASE2
NCT04107987 COMPLETED
Dysglycemia
University of Pavia
 2018-10-01 PHASE3
NCT03609892 COMPLETED
Gastric Ulcer; Chronic Gastritis; Gastric Cancer; Helicobacter Pylori Infection; Gastritis
Xijing Hospital of Digestive Diseases
 2018-08-01 PHASE4
NCT06703086 COMPLETED
Obesity; Overweight; Berberine
National Polytechnic Institute, Mexico
 2019-01-05
NCT03486496 UNKNOWN
Lung Adenocarcinoma; EGFR Mutation
Fujian Cancer Hospital
 2018-06-05 PHASE2
NCT04049396 COMPLETED
Non-Alcoholic Fatty Liver Disease
Lida Nejati
 2018-10-01
NCT02226185 COMPLETED
Colorectal Adenoma
Shanghai Jiao Tong University School of Medicine
 2014-11 PHASE2; PHASE3
NCT02082756 WITHDRAWN
Prediabetes
Xijing Hospital
 2015-11 PHASE2; PHASE3
NCT02084004 WITHDRAWN
Type 2 Diabetes Mellitus
Xijing Hospital
 2015-11 PHASE2; PHASE3
NCT03330184 COMPLETED
Berberine Hydrochloride
Xijing Hospital
 2015-10
NCT02365480 COMPLETED
Ulcerative Colitis
National Cancer Institute (NCI)
 2016-06-16 PHASE1
NCT03029390 UNKNOWN
Prediabetes; Impaired Fasting Glucose; Impaired Glucose Tolerance
University of Guadalajara
 2016-03 PHASE4
NCT03019263 COMPLETED
Dyslipidemia
Fondazione IRCCS Policlinico San Matteo di Pavia
 2017-03-31
NCT02962245 WITHDRAWN
Ulcerative Colitis
Xijing Hospital of Digestive Diseases
 2016-11 PHASE4
NCT02861261 UNKNOWN
Type 2 Diabetes
Shanghai Jiao Tong University School of Medicine
 2016-08-18 PHASE3
NCT03251716 COMPLETED
Metabolic Syndrome; Female; Schizophrenia
Tianjin Anding Hospital
 2015-01-01
NCT02806999 UNKNOWN
Hyperglycemia
Guangdong Provincial People's Hospital
 2016-07 PHASE4
NCT06426966 COMPLETED
Diabetes Mellitus; Obesity
National Polytechnic Institute, Mexico
 2016-02-01
NCT02834078 COMPLETED
Pre Diabetes
Vedic Lifesciences Pvt. Ltd.
 2015-09
NCT02633930 COMPLETED
Gastritis; Peptic Ulcer; Dyspepsia
Xijing Hospital of Digestive Diseases
 2015-12 PHASE4
NCT03548155 COMPLETED
Schizophrenia; Therapeutics
Tianjin Anding Hospital
 2014-07-24
NCT01697735 TERMINATED
Dyslipidemias
Wenzhou Medical University
 2012-09 PHASE4
NCT02296021 COMPLETED
Gastritis; Peptic Ulcer; Dyspepsia
Xijing Hospital of Digestive Diseases
 2014-11 PHASE4
NCT02936414 COMPLETED
Schizophrenia
Tianjin Anding Hospital
 2014-07
NCT02295176 COMPLETED
Metabolic Syndrome; Insulin-resistance; Left Ventricular Hypertrophy
Rottapharm
 2013-04
NCT01116167 UNKNOWN
Polycystic Ovary Syndrome
Heilongjiang University of Chinese Medicine
 2009-10
NCT01138930 UNKNOWN
Polycystic Ovary Syndrome; Obesity
Heilongjiang University of Chinese Medicine
 2010-06
NCT01696448 COMPLETED
Metabolic Syndrome
Carmel Biosciences
 2012-08
NCT00633282 COMPLETED
Nonalcoholic Fatty Liver Disease
Xin Gao
 2008-03 PHASE2
NCT02078167 COMPLETED
Hypercholesterolemia
Comitato Etico di Area Vasta Sud Est
 2009-01 PHASE4
NCT00462046 COMPLETED
Diabetes Mellitus, Type 2; Metabolic Syndrome
Shanghai Jiao Tong University School of Medicine
 2005-04 PHASE3
NCT00425009 COMPLETED
Type 2 Diabetes
Shanghai Jiao Tong University School of Medicine
 2004-01 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the Berberine (Umbellatine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Berberine directly activates AMP-activated protein kinase (AMPK) and interacts with bacterial nucleic acids, thereby inhibiting downstream lipid biosynthetic pathways and disrupting essential microbial enzymatic cascades. This targeted biochemical inhibition reduces intracellular lipid accumulation and suppresses pathogen proliferation, establishing its clinical relevance in treating metabolic syndrome, polycystic ovary syndrome, and Helicobacter pylori infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.