Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes

Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes: A Real-World Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes

Detailed Description

Pueraria lobata radix (PLR), the dried root of Pueraria lobata (Willd.) Ohwi (Family Leguminosae), is an herb with both medicinal and edible applications, historically utilized for treating diabetes. Recent research advances regarding its bioactive constituents have progressively validated PLR's potential efficacy in the adjunctive therapy of type 2 diabetes mellitus (T2DM). Animal studies demonstrate that multiple active compounds within PLR, such as puerarin and polysaccharides, exert significant hypoglycemic effects. The underlying mechanisms include improvement of insulin sensitivity, reduction of insulin resistance, enhancement of glucose tolerance, and protection of pancreatic β-cell function. Based on this evidence, puerarin injections (primarily composed of the standardized extract puerarin) are clinically employed for treating T2DM and its complications, exhibiting substantial therapeutic benefits. Clinical studies further confirm that PLR dietotherapy at conventional doses effectively assists glycemic control with a favorable safety profile. Owing to its dual designation as both a medicine and food, PLR has gained widespread adoption in the daily dietary management of T2DM patients.

However, significant uncertainties persist concerning PLR's safety under non-standard consumption patterns. For instance, some patients may consume PLR products at high doses, for extended durations, or irregularly. Furthermore, consumption occurs among special populations, such as children, pregnant or lactating women, and the elderly. Such usage patterns and dosages may substantially deviate from established recommendations. The absence of systematic safety assessments for these scenarios leaves potential risks unclarified. This safety concern is exacerbated within unregulated market environments; the lack of restrictions on PLR purchase or intake could diminish patient awareness regarding safe dosing practices, thereby elevating risks associated with non-standard use.

To address these gaps, this study will conduct a retrospective real-world investigation to systematically evaluate the safety of PLR under special consumption scenarios within T2DM populations.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Xu Zhou, M.D; Phone Number: +8618870050733; Email: zhouxu_ebm@hotmail.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

1. Diagnosis with T2DM.
2. Documented history of consuming Pueraria lobata radix (PLR) in any dosage form (e.g., dried slices, root cubes).
3. 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.
4. Occurrence of adverse events during the retrospective observation period within one month following PLR consumption.

Exclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
2. Use of PLR compound preparations (e.g., puerarin injection).
3. Unavailability of complete clinical data or patient refusal to provide essential information required for the observation period during follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pueraria lobata radix group; This group includes patients with T2DM who consumed Pueraria lobata radix in any special scenarios.
Control group; This group includes patients with T2DM who did not consume Pueraria lobata radix in any special scenarios.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Collect data from the past 6 months for each sample, with the sample sources spanning a two-year period

Collaborators and Investigators

• Sponsor: Jiangxi University of Traditional Chinese Medicine
• Collaborators: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Xu Zhou, M.D, Jiangxi University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 10, 2025
• First Submitted That Met QC Criteria: July 18, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Type 2 diabetes mellitus; Real-world study; Pueraria lobata radix; Ge Gen
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: JXUCM-DIET-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No