Ten on-going clinical trials on Berberine in 2022
What is Berberine?
More and more people in pharmaceutical and nutraceutical pay more attention to berberine, they research and study it and go on with clinical trials on it. So, what is berberine?
Berberine is a quaternary ammonium salt from the protoberberine group of benzylisoquinoline alkaloids originated from botanicals like Berberis Aristata, Chinensis Phellodendron,Berberis Vulgaris,Coptis Chinensis and goldenseal. Berberine hydrochloride is a bright yellow-colored and bitter-tasting compound.
What are the benefits of berberine yet found by clinical trials?
Berberine has multiple function. Basic studies and previous clinical studies suggest that it has definite regulatory effects on blood glucose, lipid levels and blood pressure with few adverse reactions. Therefore, berberine is a nonprescription drug for diarrhea in China and as dietary supplements, it is an active natural ingredient for lowering sugar blood, lower cholesterol and for diabetes treatment.
The on-going clinical trials on berberine in a brief.
There are many on-going clinical trials on berberine worldwide including Italy, Sweden, USA, China and Africa. The trials on berberine are generally for
✅Mostly effects on the Metabolism Disorders: high blood pressure, obesity, diabetes etc. A unique one is treatment for Schizophrenia Patients with Metabolic Syndrome.
✅Improving the bioavailability of berberine.
✅Regulating the intestinal flora.
✅A brand new trial for Safety and efficacy of in managing COVID-19 disease.
The ten on-going clinical trials on berberine in 2022.
1.Clinical Trial of Effect of Gamma-cyclodextrin on the Bioavailability of Berberine.
Brief
In this study, They evaluate the relative bioavailability of Berberine (BB) from capsules containing Indian Barberry (Berberis Aristata DC.) in the blood plasma of healthy subjects after oral administration of
A. Capsules containing Berberine and GCD (BBA, Berberine incorporated in gamma cyclodextrin)
B. Capsules containing Berberine (BB, Dietary Supplement) – (reference product).
Conditions
Drug Absorption
Treatment
Combination product BBA
Dietary supplement BB
Phase
Phase1
Study Start (Estimated)
September 2021
Study Completion (Estimated) December 2022
2.Clinical Trial to Compare the Efficacy and Safety of Metformin and Berberine for Schizophrenia Patients with Metabolic Syndrome.
Brief
Medical herb based berberine has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, there’s few study reported about the berberine modification on lipid metabolism in schizophrenia. Metformin have been used for metabolic abnormalities in schizophrenia. Experimental stage studies indicated that berberine and Metformin shows same effects. This study is to compare the efficacy and safety of berberine and metformin for preventing metabolic dysfunction in schizophrenia patients.
Conditions
Schizophrenia Metabolic Syndrome
Treatment
Drug Berberine
Drag Metformin
Phase
Phase4
Study Start (Actual)
December 1,2021
Primary Completion (Estimated) October 1,2023
3.Clinical Trials on Effectiveness of the Assumption of a Berberine Phytosome-based Supplement on the Hematic Values of Glucose in a Group of Patients With Altered Fasting Glucose
Brief
This study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.
Conditions
Glucose Metabolism Disorders
Treatment
Dietary Supplement: Berberine phytosome
Phase
N/A
Study Start (Actual)
March2,2020
Primary Completion (Estimated) July 25,2022
4.Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers
Brief
Berberine is a dietary supplement that comes from the roots, stems, and bark of various plants and has been used for centuries in traditional Chinese medicine. It may help lower cholesterol, lower blood sugar, and reduce inflammation. Very few studies have been done in the United States to show how berberine effects cholesterol and blood sugar. This study is looking to see how berberine changes cholesterol and blood sugar, and to see how well it is tolerated. Berberine is not a prescription medication but it appears to have similar actions to common prescription medications to lower cholesterol like statins, and to lower blood sugar like metformin. We are studying berberine to see if it may be a good option for people that do not want to take prescription medications.
Conditions
Metabolic Syndrome
Treatment
Dietary supplement berberine
Phase
N/A
Study Start (Actual)
August 20,2019
Primary Completion (Estimated) October 2024
5.Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults(LADA)
Brief
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.
Conditions
Type 1 Diabetes Mellitus Autoimmune diabetes
Treatment
Drug berberine
Drug Inulin
Together with the two drugs placebo tablets respectively
Phase
Phase4
Study Start (Estimated)
May 2022
Primary Completion (Estimated) December 2025
6.Evaluating the Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis
Brief
The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.
Conditions
Non-alcoholic steatohepatitis
Intervention/Treatment
Behavioral lifestyle intervention
Drug berberine
Phase
Phase4
Study Start (Actual)
August 16,2017
Study Completion (Estimated) July 2022
7.Safety and Efficacy of COVIDEX™ Therapy in Management of Adult Covid-19 Patients in Uganda: A Randomized Double-blind Placebo Controlled Adaptive Phase 2 B Clinical Trial.
Brief
The SARS-CoV-2 pandemic continues to grow, but the current supplies of protective vaccines are too low to cover the worldwide demand, researchers worldwide are urgently looking for interventions to prevent new infections, prevent disease progression, and lessen disease severity for those already infected in consequently.
Number of claims on efficacy of herbal remedies on COVID-19 have been made. In Uganda, one of such herbal remedies is COVIDEX, this study therefore seeks to investigate the safety and efficacy of COVIDEX in the management of COVID-19.
Conditions
COVID-19
Treatment
Covidex(a herbal formulation containing berberine as a primary anti-SARSCOV-2 compound)
Phase
Phase2
Study Start (Estimated)
March 1,2022
Study Completion (Estimated) November30, 2022
8.Endoscopic and Microbiological Assessment of the Effect of Carvedilol Combined With Berberine on GOV in Cirrhosis: a Prospective Cohort Study.
Brief
Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. A lot of studies have shown that the imbalance of flora and the progress of portal hypertension are mutually causal. Berberine can regulate the intestinal flora.In this study, we evaluated the effect of carvedilol and berberine on reducing portal vein pressure by observing the changes of endoscopy，endoscopic ultrasonography and intestinal flora.
Conditions
Cirrhosis Due to Hepatitis B
Cirrhosis Due to Hepatitis C
Gastroesophageal varices
Treatment
Drug Carvedilol
Drug Berberine
Phase
Phase3
Study Start (Estimated)
November 1,2021
Study Completion (Estimated) October31, 2023
9.Efficacy and Safety of Berberine on Primary Prevention of Cardiovascular Diseases and Diabetes in Metabolic Syndrome: a Randomized, Controlled Trial.
Brief
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).
Conditions
Metabolic Syndrome
Treatment/Intervention
Drug Berberine
Behavioral Healthy lifestyle intervention
Phase
Phase4
Study Start (Estimated)
December,2021
Primary Completion (Estimated) December 2026
10.Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication
Brief
The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy or vonoprazan -containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test, rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Conditions
Helicobacter Pylori Infection
Chronic Gastritis
Treatment/Intervention
Drug Berberine
Drug Amoxicillin
Drug Rabeprazole
Drug Bismuth
Drug Clarithromycin
Phase
Phase4
Study Start (Estimated)
December1 ,2021
Study Completion (Estimated) June 30, 2022
More clinical trials on related natural extract as below.
Reference
1.Clinical trials data is sourced from US FDA.
2. Other news about natural ingredients for treatment covid-19.
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