Clinical trials: Berberine
Pre Diabetes
Effect of BGG on Glucose Metabolism and Other Markers of Metabolic Syndrome
According to the International Diabetes Federation, one in every 12 individuals is a diabetic (about 8% of the world population).
- Trial name
- Glucogold (NCT02834078)
- Testing
- BGG
- Volunteers
- 126 people
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Phase I and Phase II Metabolites of Berberine
Metabolic Differences Between Dihydroberberine and Micellar Berberine
Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers.
- Trial name
- NCT06202157
- Testing
- LMB, DHB
- Where
- Canada
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Factors Group of Nutritional Companies Inc.
Obesity & Overweight, Circadian Rhythm Disorders
Effects of Akkermansia Muciniphila and Berberine Supplementation on Insulin Sensitivity in Night-shift Workers
Night shift work is associated with an increased risk of obesity, insulin resistance, and cardiometabolic disorders, largely due to circadian misalignment, disrupted sleep, and altered eating patterns.
- Conditions
- Obesity & Overweight, Circadian Rhythm Disorders, Gut Microbiota Modulation, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- Trial name
- Shift2Health (NCT07440147)
- Testing
- Verum (A)
- Where
- Austria
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- FH Joanneum Gesellschaft mbH
Metabolism Disorder, Nutraceutical
A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
This randomized, triple-blind, placebo-controlled study will evaluate the efficacy of Diaberine, a berberine-based nutraceutical, in aiding blood sugar regulation and metabolism in 80 participants over 24 weeks.
- Trial name
- NCT06700915
- Testing
- Diaberine
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Ultimate International, Inc.
T2DM (Type 2 Diabetes Mellitus)
Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes
The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone.
- Trial name
- SYMPHONY-1 (NCT06350890)
- Testing
- HTD1801
- Where
- 56 sites in China
- Volunteers
- 408 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
T2DM (Type 2 Diabetes Mellitus)
Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
- Trial name
- HARMONY (NCT06415773)
- Testing
- HTD1801, Dapagliflozin
- Where
- 53 sites in China
- Volunteers
- 367 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
Type 2 Diabetes Mellitus
A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.
- Trial name
- NCT06411275
- Testing
- HTD1801
- Where
- 14 sites in China
- Volunteers
- 113 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
Drug Absorption
Effect of Gamma-cyclodextrin on the Bioavailability of Berberine
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…
- Trial name
- NCT04918667
- Testing
- Berberine incorporated in gamma cyclodextrin, Berberine
- Where
- 4 sites in Armenia, Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- EuroPharma, Inc.
Metabolic Syndrome
The BANGALORE Study; Combination of Berberine, Lipoic Acid, and Picrorhiza
Though medical treatment has been effective in the treatment of cardiometabolic diseases (including coronary atherosclerosis and diabetes mellitus), the incidence of these disorders continues to be high.
- Trial name
- CAR-191 (NCT01696448)
- Testing
- CAR-191
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Carmel Biosciences
Type 2 Diabetes Mellitus
Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.
- Trial name
- SYMPHONY-2 (NCT06353347)
- Testing
- HTD1801
- Where
- 64 sites in China
- Volunteers
- 551 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
Pharmacokinetics
Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels
The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation.
- Trial name
- NCT05370261
- Testing
- Berberine LipoMicel, Regular Berberine hard-gels
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Factors Group of Nutritional Companies Inc.
Hyperlipidemia, Low-density-lipoprotein-type
Combined Effects of Bioactive Compounds in Lipid Profile
The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the…
- Conditions
- Hyperlipidemia, Low-density-lipoprotein-type, Elevated Triglycerides
- Trial name
- ARM-PLUS-LDL (NCT01562080)
- Testing
- Armolipid Plus
- Where
- Spain
- Volunteers
- 118 people
- Sponsor
- Rottapharm Spain
Metabolic Syndrome, Insulin-resistance
Metabolic and Cardiovascular Effects of Armolipid Plus in Subjects With Metabolic Syndrome
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass.
- Conditions
- Metabolic Syndrome, Insulin-resistance, Left Ventricular Hypertrophy
- Trial name
- ARMP-11 (NCT02295176)
- Testing
- Armolipid Plus
- Where
- 3 sites in Italy
- Volunteers
- 159 people
- Sponsor
- Rottapharm