Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus

Summary

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).

Eligibility

Inclusion Criteria:

1. 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).
2. Age between 18 and 80 years old.
3. Untreated patients or those currently receiving regular anti-diabetic medication therapy, including oral hypoglycemic drugs and insulin, with no restrictions on types or doses.
4. Blood glucose levels not effectively controlled in the three months prior to baseline screening: HbA1c between 6.5% and 10.5%.
5. Willingness to comply with dietary control requirements during the study.
6. Voluntary participation and signing of informed consent form.

Exclusion Criteria:

1. Type 1 diabetes, gestational diabetes, and special types of diabetes.
2. History of diabetic acute complications, including ketoacidosis, hyperosmolar coma, and lactic acidosis.
3. Pregnant or lactating women, or women planning pregnancy.
4. Allergy history to Pueraria lobata radix.
5. Severe dysfunction of vital organs such as heart, liver, and kidney, malignant tumors, or severe mental disorders.
6. Anticipated poor compliance or language communication impairments.
7. Currently participating in other clinical trials.

Conditions2

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