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Sponsors and Collaborators: |
Shanghai Jiao Tong University of Medicine National Institutes of Health (NIH) |
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Information provided by: | Shanghai Jiao Tong University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00425009 |
The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Berberine Drug: Metformin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes |
Estimated Enrollment: | 70 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2004 |
Type 2 diabetes is health threats worldwide. However, treatment of this disease is limited by availability of effective medicines. All of the existing oral hypoglycemic agents have secondary failure after long term administration. Thus, new oral medicines are needed for long term control of blood glucose in patients with type 2 diabetes. In diabetes care, dietary approaches have drawn more and more attention in the prevention and treatment of hyperglycemia. Generally regarded as safe (GRAS) plants have been widely used for their benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes. Numerous botanical products such as pigments that include anthocyanins and flavonoids have been consumed or studied for anti-obesity and anti-diabetes. However, most of these botanical products are mixtures of multiple compounds. It is difficult to control their quality in the study or production. Up to now, as a single purified compound, berberine is demonstrated to have hypoglycemic effect in vitro and in vivo. Berberine is the main active component of Coptis chinensis French, which was used for thousands of years in China in the treatment of human diseases including diabetes.
Comparison(s): Effects of berberine compared with metformin in newly diagnosed type 2 diabetic patients.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | |
Shanghai, China, 200092 |
Principal Investigator: | Jun Yin, MD, PhD | Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
Study ID Numbers: | XH-2002-Clin4 |
Study First Received: | January 18, 2007 |
Last Updated: | January 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00425009 |
Health Authority: | China: State Food and Drug Administration |
Berberine Type 2 diabetes Treatment |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |