This real-world study aims to investigate the association between the consumption of Pueraria lobata radix and adverse events in patients with type 2 diabetes mellitus (T2DM) under special scenarios. By retrospectively analyzing the clinical data of patients with T2DM, we will evaluate the safety profile of Pueraria lobata radix in different special populations, identify potential risk factors, and provide evidence-based support for the safe consumption and clinical use of Pueraria lobata radix.
Diagnosis with T2DM.
Documented history of consuming Pueraria lobata radix (PLR) in any dosage form (e.g., dried slices, root cubes).
Fulfillment of at least one of the following special scenarios: 1) Excessive dosage: Daily PLR intake ≥ twice the maximum dose specified in the Chinese Pharmacopoeia; 2) Long-term consumption: PLR consumption duration ≥ three months with frequency ≥ three times weekly; 3) Advanced age: ≥ 80 years; 4) Pregnancy; 5) Lactation; 6) Allergic constitution: History of any food or drug allergy; 7) Liver dysfunction: Clinical diagnosis of liver cirrhosis or chronic liver failure, or laboratory findings of total bilirubin > 1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2 × ULN; 8) Renal insufficiency: Clinical diagnosis of diabetic nephropathy or chronic nephritis with renal function impairment, or serum creatinine > 120% of ULN.
Occurrence of adverse events during the retrospective observation period within one month following PLR consumption.
Diagnosis of type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
Use of PLR compound preparations (e.g., puerarin injection).
Unavailability of complete clinical data or patient refusal to provide essential information required for the observation period during follow-up.
The study population will comprise individuals diagnosed with T2DM. Diagnosis will be established according to international diabetes guidelines, defined as meeting any of the following criteria: a fasting blood glucose (FBG) level ≥126 mg/dL (7.0 mmol/L), a blood glucose level ≥200 mg/dL (11.1 mmol/L) measured 2 hours after a 75-g oral glucose tolerance test, or a glycated hemoglobin (HbA1c) level ≥6.5% (48 mmol/mol).
Cohort
Retrospective
Not listed
Incidence of individual adverse events
The between-group differences in the incidence of individual adverse events will be compared across the eight predefined special consumption scenarios: 1) excessive dosage, 2) long-term consumption, 3) advanced age, 4) pregnancy, 5) lactation, 6) allergic constitution, 7) liver dysfunction, and 8) renal insufficiency.
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Jiangxi University of Traditional Chinese Medicine
Lead sponsor
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborator
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