Berberine (vs dihydroberberine) trials recruiting now
11 registrations that name berberine as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 11 registrations
Status
Phase
All 11 registrations
RecruitingNCT06629051
6-year Follow-up Data After the Berberine Intervention Trial
Observational
Shanghai Jiao Tong University School of Medicine
About 891 people
Starts Oct 4, 2024 (estimated)
In plain words An observational study of berberine in people of any age, run by Shanghai Jiao Tong University School of Medicine. It plans to enroll about 891 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people of any age. Conditions: Colorectal Adenoma; Colorectal Cancer Control and Prevention; Colorectal Polyps.
What it tests, as registered
Berberine Hydrochloride; Placebo
Registered summary
Colorectal cancer (CRC) is a common malignancy of the digestive tract, which constitutes a major public health burden. Almost 90% of CRC cases progress from precursor adenomatous polyps through adenoma-carcinoma sequence. Endoscopic detection and removal of colorectal adenoma (CRA) could reduce the incidence and mortality risk of CRC, but the recurrence rate is still high. Therefore, chemoprevention is quite important, not only solve the urgent public health problem, but also be cost-effective. The full summary is on the listing.
Where, as registered
No US site; China (1).
RecruitingNCT07420231
Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort
No phase
Université Catholique de Louvain
About 140 people
Started Mar 16, 2026
In plain words A study of berberine in people 18 to 75, run by Université Catholique de Louvain. It plans to enroll about 140 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Intestinal Discomfort; Abdominal Pain/ Discomfort.
Woman or man, aged of 18 to 75 years (inclusive);
Subject with a measurable level of intestinal discomfort, assessed using a questionnaire inspired by the ROME IV criteria. Eligible participants must meet all of the following conditions:
Experience recurrent abdominal pain present for at least three months and occurring on a regular basis;
The abdominal discomfort must have a low to moderate impact on quality of life;
14 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Berberine; Bifidobacterium longum; Bifidobacterium longum and Berberine; Placebo
Registered summary
This study aims to investigate the beneficial effects of the daily consumption of a synbiotic formulation-combining a prebiotic (Berberine, BBR) and a postbiotic (inactivated Bifidobacterium Longum, B.longum)-in adults experiencing intestinal discomfort.
Where, as registered
No US site; Belgium (1).
RecruitingNCT03378934
Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention
Phase 4
Peking Union Medical College Hospital
About 64 people
Started Sep 26, 2018
In plain words A Phase 4 study of berberine in people 18 to 70, run by Peking Union Medical College Hospital. It plans to enroll about 64 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 70. Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention.
Provision of written informed consent.
Aged 18-70 years, male or female.
Currently, > 8 but ≤ 40 weeks after index percutaneous coronary intervention (PCI) .
Receiving dual antiplatelet therapy (DAPT) with aspirin (Bayaspirin TM) 100 mg once daily and clopidogrel (Plavix TM) 75 mg once daily for ≥ 7 days.
5 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Berberine; Standard treatment; Aspirin; Clopidogrel
Registered summary
The APLABE-PCI is a single-center, randomized, open-label, controlled, dose-escalating, parallel-group study, which is designed to assess the anti-platelet effect of berberine in approximately 64 patients receiving aspirin and clopidogrel who are at \> 8 but ≤ 40 weeks after percutaneous coronary intervention.
Where, as registered
No US site; China (1).
Not yet recruitingNCT05105321
Cardiovascular Diseases and Diabetes Prevention Programme in Metabolic Syndrome (CDPP)
Phase 4
Tang Yida
About 5,200 people
Starts Dec 2021 (estimated)
In plain words A Phase 4 study of berberine in people 40 to 75, run by Tang Yida. It plans to enroll about 5,200 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 40 to 75. Conditions: Metabolic Syndrome.
Patients diagnosed with metabolic syndrome aged 40-75 years old.
Metabolic syndrome was defined according to the Chinese Guidelines for the Prevention and Treatment of Dyslipidemia in Adults (revised edition 2016).
The exclusion criteria are on the listing.
What it tests, as registered
Berberine; Healthy lifestyle intervention
Registered summary
The metabolic syndrome population is at high-risk of cardiovascular diseases and diabetes. How to effectively control the risk factors of this population is the key to primary prevention of cardiovascular diseases and diabetes in China. This study aims to explore the efficacy and safety of an intervention strategy with berberine that can effectively treat a variety of risk factors (hyperglycemia, dyslipidemia, hypertension).
Where, as registered
No US site; China (1).
Not yet recruitingNCT04698330
Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA
Phase 4
Second Xiangya Hospital of Central South University
About 240 people
Starts May 2022 (estimated)
In plain words A Phase 4 study of berberine in people 18 to 70, run by Second Xiangya Hospital of Central South University. It plans to enroll about 240 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 70. Conditions: Type 1 Diabetes Mellitus; Autoimmune Diabetes.
Diabetes diagnosed according to the report of WHO in 1999；
Meet the Chinese Diabetes Society diagnostic criteria (2012) for LADA: (1)glutamic acid decarboxylase antibody (GADA) positive; (2) age at diagnosis ≧ 18 years old; (3) independent on insulin for more than 6 months after diagnosis;
Aged between 18 and 70 years old;
7.0%≤HbA1c ≤10.0%;
2 more inclusion criteria and the exclusion criteria are on the listing.
The primary purpose of this study is to evaluate the effects of oral berberine (BBR) and inulin combined with insulin therapy on diabetes care in patients with LADA.
Where, as registered
No US site; China (1).
Not yet recruitingNCT07129460
Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia
Phase 4
Xijing Hospital of Digestive Diseases
About 204 people
Starts Oct 1, 2025 (estimated)
In plain words A Phase 4 study of berberine in people 18 to 75, run by Xijing Hospital of Digestive Diseases. It plans to enroll about 204 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Gastric Intestinal Metaplasia.
patients aged from 18 to 75 years old.
patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.
patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.
The exclusion criteria are on the listing.
What it tests, as registered
Berberine hydrochloride; Placebo
Registered summary
The goal of this clinical trial is to investigate the efficacy of Berberine in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of Berberine. The main questions it aims to answer are: Does Berberine promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Berberine? Researchers will compare Berberine to a placebo (a look-alike substance that contains no drug) to see if uBerberine is effective in treating gastric intestinal metaplasia. The full summary is on the listing.
Where, as registered
No sites listed yet.
Not yet recruitingNCT07465575
Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)
No phase
Liaquat University of Medical & Health Sciences
About 150 people
Starts Mar 16, 2026 (estimated)
In plain words A study of berberine in female participants 18 to 40, run by Liaquat University of Medical & Health Sciences. It plans to enroll about 150 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 40. Conditions: Polycystic Ovary Syndrome.
Women aged 18-40 years
Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
Body mass index (BMI) ≥ 25 kg/m²
Evidence of insulin resistance (HOMA-IR above normal range)
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Berberine Phytosome (Sophy®); Lifestyle Advice
Registered summary
This multicenter, randomized, controlled clinical trial aims to evaluate the effectiveness of berberine phytosome supplementation in improving signs and symptoms associated with polycystic ovary syndrome (PCOS). Women presenting with clinical features suggestive of PCOS, including hirsutism, acne, menstrual irregularities, and overweight, will be enrolled. The full summary is on the listing.
Where, as registered
No US site; Italy (1).
Not yet recruitingNCT06911983
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
No phase
S.LAB (SOLOWAYS)
About 60 people
Starts Jul 1, 2025 (estimated)
In plain words A study of berberine in people 30 to 65, run by S.LAB (SOLOWAYS). It plans to enroll about 60 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 30 to 65. Conditions: Diabetes Mellitis.
Adults aged 30-65 years;
Newly diagnosed T2DM ≤1 year;
Baseline HbA1c: 7.0-9.0% (53-75 mmol/mol);
No prior use of antihyperglycemic agents or ≤4 weeks of usage;
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Metformin; Berberine
Registered summary
This pilot 12-week randomized open-label study compares metformin and berberine in newly diagnosed type 2 diabetes patients stratified by the TCF7L2 (rs7903146) genotype (TT vs. CC). The primary goal is to assess changes in HbA1c between metformin and berberine treated groups within each genotype. Secondary outcomes include fasting and postprandial glucose, insulin levels, HOMA-IR, body weight/BMI, lipid profile and adverse events. The full summary is on the listing.
Where, as registered
No US site; Russia (1).
Not yet recruitingNCT07541898
Effects of Berberine on Cardiometabolic Outcomes
No phase
University of Central Lancashire
About 40 people
Starts Jul 1, 2026 (estimated)
In plain words A study of berberine in people 18 to 65, run by University of Central Lancashire. It plans to enroll about 40 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 65; healthy volunteers accepted. Conditions: Cardiometabolic Syndrome.
Healthy
Between 18 \& 65 years
Non-smoker
BMI < 30
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Berberine; Placebo
Registered summary
Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Berberine may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.
Where, as registered
No sites listed yet.
Not yet recruitingNCT07519681
Effects of Berberine on the Human Gut Microbiome
No phase
Jing-yuan Fang, MD, Ph. D
About 20 people
Starts May 15, 2026 (estimated)
In plain words A study of berberine in people 18 to 75, run by Jing-yuan Fang, MD, Ph. D. It plans to enroll about 20 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75; healthy volunteers accepted. Conditions: Colorectal Adenomas; Colorectal Cancers.
Aged 18-75 years;
Had at least one but no more than six histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas) removed within 6 months prior to enrollment;
Provide informed consent for this study and are able to comply with the requirements for collecting qualified stool specimens, peripheral blood specimens, and providing relevant lifestyle and medical history information.
Aged 18-75 years;
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Berberine Hydrochloride
Registered summary
Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the human gut microbiome.
Where, as registered
No sites listed yet.
Not yet recruitingNCT04918667
Effect of Gamma-cyclodextrin on the Bioavailability of Berberine
Phase 1
EuroPharma, Inc.
About 16 people
Starts Sep 2024 (estimated)
In plain words A Phase 1 study of berberine in people 18 to 60, run by EuroPharma, Inc.. It plans to enroll about 16 people at 4 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 60; healthy volunteers accepted. Conditions: Drug Absorption.
Healthy volunteers, as determined by medical history, physical examination, and clinical laboratory testing,
Willingness to stay in the unit overnight for the duration of the study,
Provide a signed written informed consent.
The exclusion criteria are on the listing.
What it tests, as registered
Berberine incorporated in gamma cyclodextrin; Berberine
Registered summary
In this study, we will evaluate the relative bioavailability of Berberine (BB) from capsules containing Indian Barberry (Berberis aristate DC.) Bark and Root Extract in the blood plasma of healthy subjects after oral administration of: A. Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).