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Effects of Kudzu Root (Gegen) on Drug-Metabolizing Enzymes and Blood Clotting in Healthy Volunteers
Sponsor: Chinese University of Hong Kong
Summary
Purpose: The purpose of this study is to understand how the traditional herbal medicine kudzu root (Gegen, Radix Puerariae lobatae) affects the activity of drug metabolizing enzymes in the body, and whether this could lead to interactions with other medicines. Background: Many medicines are broken down in the body by enzymes called cytochrome P450 (CYP) enzymes. Preclinical data suggest that Gegen can inhibit CYP enzymes, which may lead to herb-drug interactions; however, robust clinical evidence in humans remains insufficient. Participants: This study recruited 56 healthy Chinese adults, who were randomly assigned to parallel low and high dose Gegen groups; 52 participants finished the study. Interventions: Participants took a mixture of probe medicines known as a CYP probe cocktail to measure baseline CYP enzyme activity. After receiving either low or high dose Gegen, they received the probe cocktail again to detect changes in enzyme activity. Blood samples were collected to test the probe medicines, their breakdown products, and markers for blood clotting and blood vessel health. Outcome Measures: Primary outcomes include changes in blood levels and metabolic ratios of probe medicines. These values reflect differences in CYP enzyme activity with and without Gegen, and are compared across low and high dose groups. Hypothesis: The study hypothesized that Gegen alters CYP enzyme activity, and that the magnitude of this effect varies with Gegen dose.
Official title: Clinical Evaluations of CYP 450 Inhibition and Anticoagulation Biomarker Alteration by Radix Puerariae Lobatae (Gegen): Impact on Its Potential Herb-drug Interactions
Key Details
Gender
All
Age Range
20 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2022-08-08
Completion Date
2023-04-28
Last Updated
2026-09-16
Healthy Volunteers
Yes
Conditions
Interventions
Arm 1: Radix Puerariae lobatae (Gegen)
Granules of the dried root of Pueraria lobata (listed in the Hong Kong Chinese Materia Medica Standards; Chinese Pharmacopoeia monograph Radix Puerariae Lobatae).
Arm 1: Six-probe drug cocktail
Single oral dose of a cocktail comprising caffeine (CYP1A2), efavirenz (CYP2B6), losartan (CYP2C9), omeprazole (CYP2C19), metoprolol (CYP2D6), and midazolam (CYP3A4).
Arm 2: Radix Puerariae lobatae (Gegen)
Granules of the dried root of Pueraria lobata (listed in the Hong Kong Chinese Materia Medica Standards; Chinese Pharmacopoeia monograph Radix Puerariae Lobatae).
Arm 2: Six-probe drug cocktail
Single oral dose of a cocktail comprising caffeine (CYP1A2), efavirenz (CYP2B6), losartan (CYP2C9), omeprazole (CYP2C19), metoprolol (CYP2D6), and midazolam (CYP3A4).
Locations (1)
The Chinese University of Hong Kong Phase 1 Clinical Trial Centre
Hong Kong, Hong Kong