Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03772262 · ClinicalTrials.gov registry record · Early Phase 1
Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach
A Early Phase 1 study, sponsored by Washington State University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT03772262 is a Early Phase 1 study that has completed, run by Washington State University. The registered enrollment target is 16 participants.
The verdict
NCT03772262, a Early Phase 1 study, has completed, sponsored by Washington State University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Goldenseal is a botanical natural product commonly used to self-treat symptoms of the common cold and many digestive disorders. Goldenseal products typically contain the isoquinoline alkaloids berberine, hydrastine, and hydrastinine. These constituents contain a methylenedioxyphenyl ring, a 'structural alert' that can lead to irreversible inhibition of drug metabolizing enzymes, particularly the cytochromes P450 (CYPs). Clinical studies involving healthy volunteers demonstrated that, compared to baseline (absence of goldenseal), CYP2D6 and CYP3A activities were reduced by 40-60% following treatment with goldenseal. Compared to the CYPs, the effects of goldenseal products on drug transporters are understudied, particularly in human subjects. Using a 'cocktail' consisting of 'probe' drug substrates for CYP3A and various transporters, the effects of goldenseal on the pharmacokinetics of each probe drug will be examined in healthy volunteers. Results will provide useful information about the risk of co-consuming goldenseal with additional drugs that are substrates for transporters.
Interventions
- DRUG Metformin
- DRUG Furosemide
- DRUG Midazolam oral solution
- DIETARY_SUPPLEMENT goldenseal
- DRUG Rosuvastatin Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2019-03-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03772262
The ClinicalTrials.gov registry entry for NCT03772262 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington State University, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Metformin is the first listed.
NCT03772262 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03772262 about?
NCT03772262 is a clinical study titled "Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach". Goldenseal is a botanical natural product commonly used to self-treat symptoms of the common cold and many digestive disorders. Goldenseal products typically contain the isoquinoline alkaloids berberine, hydrastine, and hydrastinine. These constituents contain a methylenedioxyphenyl ring, a 'structu...
What is the current status of trial NCT03772262?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2018-04-05. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT03772262?
The interventions under investigation include: Metformin (DRUG), Furosemide (DRUG), Midazolam oral solution (DRUG), goldenseal (DIETARY_SUPPLEMENT), Rosuvastatin Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03772262?
This trial is sponsored by Washington State University, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.