NCT07079085

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Jiangxi University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Type 2 Diabetes

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: China