Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients
Status:
Recruiting
Trial end date:
2022-08-31
Target enrollment:
Participant gender:
Summary
Supplements containing goldenseal, a perennial herb native to North America, have
consistently ranked among the top 20 highest selling natural products throughout the last
decade. Goldenseal products are marketed as licensed natural health products in Canada and as
dietary supplements in the United States. Natural products made from dried roots of the
goldenseal plant are purported to have therapeutic value and are used to self-treat a range
of medical complications, including the common cold, allergic rhinitis, and digestive
disorders, such as diarrhea and constipation. Based on a previous clinical study, goldenseal
have been shown to precipitate pharmacokinetic interactions with metformin in healthy
volunteers. This follow-up study aims to evaluate the goldenseal-metformin interaction in
type 2 diabetic patients. Results from this proposed clinical study will (1) characterize the
pharmacokinetic interaction between the botanical dietary supplement goldenseal and
anti-diabetic drug metformin, (2) provide evidence-based recommendations to mitigate drug
interaction risks, and (3) contribute to the development of a comprehensive strategy for
effectively assessing other potential natural-product drug interactions.
Phase:
Early Phase 1
Details
Lead Sponsor:
Washington State University
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)