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

NCT07079085 | Not Yet Recruiting DMC

• 1 other identifier: JXUCM-DIET-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Pueraria lobata radix; Ge Gen; Type 2 diabetes mellitus; Safety; Real-world study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator

Study Sites (1)

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xu Zhou, M.D

  Jiangxi University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Zhou, M.D

CONTACT

+8618870050733; zhouxu_ebm@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)