Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00808860

Enrollment

Registered

2008-12-16

Start date

2008-02-29

Completion date

2008-12-31

Last updated

2010-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Herbal medicine, Type 2 diabetes, Gynostemma pentaphyllum Tea, Insulin sensitivity, add-on

Brief summary

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.

Detailed description

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, the investigators 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, the investigators also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

Interventions

DIETARY_SUPPLEMENTGP group

Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally

DIETARY_SUPPLEMENTPlacebo group

Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Newly diagnosed, drug-naive patients with type 2 diabetes * Fasting plasma glucose (FPG)9.0-14.0 mmol/L * HbA1C 9-13%

Exclusion criteria

* Type 1 diabetes * Liver failure * Kidney failure

Design outcomes

Primary

Measure	Time frame
fasting plasma glucose	12 weeks
HbA1C (glycosylated hemoglobin)	12 weeks

Secondary

Measure	Time frame
plasma lipids (TG, Cholesterol, HDL-, LDL-)	12 weeks
liver enzymes (AST, ALT)	12 weeks
body weight (BMI, hip-weight ratio)	12 weeks
blood pressure	12 weeks
kidney function (S-creatinine, S-BUN)	12 weeks

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026