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NCT05081583 · ClinicalTrials.gov registry record · Early Phase 1
Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients
A Early Phase 1 study, sponsored by Washington State University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
NCT05081583: Completed Early Phase 1 study, sponsored by Washington State University.
NCT05081583 is a Early Phase 1 study that has completed, run by Washington State University. The registered enrollment target is 22 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05081583, a Early Phase 1 study, has completed, sponsored by Washington State University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
Area under the plasma concentration time curve of metformin
Interventions
- DRUG Midazolam Hcl 1Mg/Ml Inj
- DIETARY_SUPPLEMENT Goldenseal (Hydrastis canadensis)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2023-08-31 |
| Phase | Early Phase 1 |
What the finished NCT05081583 record still lists
NCT05081583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam Hcl 1Mg/Ml Inj is the first listed.
NCT05081583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05081583 about?
NCT05081583 is a clinical study titled "Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients". 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 ...
What is the current status of trial NCT05081583?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2021-09-16. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT05081583?
The interventions under investigation include: Midazolam Hcl 1Mg/Ml Inj (DRUG), Goldenseal (Hydrastis canadensis) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05081583?
This trial is sponsored by Washington State University, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05081583's enrollment target sits among peer trials
22 1104th of 2000 higher than 872 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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