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Sponsors and Collaborators: |
Hanoi Medical University Karolinska Institutet Swedish International Developmental Agency (SIDA), Stockholm, Sweden |
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Information provided by: | Hanoi Medical University |
ClinicalTrials.gov Identifier: | NCT00808860 |
The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4 and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver function.
Condition | Intervention | Phase |
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Type 2 Diabetes |
Dietary Supplement: GP group Dietary Supplement: Placebo group |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as Add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients |
Enrollment: | 25 |
Study Start Date: | February 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo group: Placebo Comparator
Gliclazide + Placebo tea
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Dietary Supplement: Placebo group
Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally
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GP group: Active Comparator
Gliclazide + Gynostemma pentaphyllum tea
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Dietary Supplement: GP group
Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally
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In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic patients, but effects of these extracts have not been studied adequately. Based on previous results in experimental animal, we have selected the plant Gynostemma pentapyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rat. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes.In addition to monitoring effects plasma glucose regulation, we also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Vietnam | |
National Institute of Gerontology, HMU | |
Hanoi, Vietnam |
Study Director: | Claes-Goran Ostenson, MD, PhD | Karolinska Institute |
Study ID Numbers: | Diabetes II-Study 2, Study 2 |
Study First Received: | December 15, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00808860 |
Health Authority: | Vietnam: Ministry of Health |
Herbal medicine Type 2 diabetes Gynostemma pentaphyllum Tea Insulin sensitivity add-on |
Metabolic Diseases Gliclazide Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |