As a dietary herb, pueraria lobata radix (PLR) has been showed to have hypoglycemic effects in animal experiments. However, there is currently a lack of evidence from randomized controlled trials. Therefore, this randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus (T2DM).
Diagnosis of type 2 diabetes mellitus according to the International Diabetes Guidelines: fasting blood glucose (FBG) ≥ 126 mg/dl (7.0 mmol/l) or 2-hour postprandial blood glucose ≥ 200 mg/dL (11.1 mmol/l), or HbA1c ≥ 6.5% (48 mmol/mol).
Age between 18 and 80 years old.
Untreated patients or those currently receiving regular anti-diabetic medication therapy, including oral hypoglycemic drugs and insulin, with no restrictions on types or doses.
Blood glucose levels not effectively controlled in the three months prior to baseline screening: HbA1c between 6.5% and 10.5%.
Type 1 diabetes, gestational diabetes, and special types of diabetes.
History of diabetic acute complications, including ketoacidosis, hyperosmolar coma, and lactic acidosis.
Pregnant or lactating women, or women planning pregnancy.
Allergy history to Pueraria lobata radix.
Parallel
Pueraria lobata radix
DrugThe dose of Pueraria lobata radix granules is one sachet per day, 1.5g per sachet, which equivalent to 15 g of the original herb.
HbA1c
Changes from baseline in HbA1c levels
HbA1c
Changes from baseline in HbA1c levels
HbA1c response rate
Proportion of patients with HbA1c \< 7.0%
Fasting blood glucose
Changes from baseline in fasting blood glucose levels
Two-hour postprandial glucose
Changes from baseline in two-hour postprandial glucose levels
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Jiangxi University of Traditional Chinese Medicine
Lead sponsor
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
