Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00006330 · ClinicalTrials.gov registry record · NA
Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
A NA study, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- NA
- Development phase
NCT00006330 is a NA study that has completed, run by National Center for Research Resources (NCRR).
The verdict
NCT00006330, a NA study, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- NA
- Development phase
Study Summary
Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.
Interventions
- DRUG Digoxin
- DRUG Hawthorn
Trial Details
| Field | Value |
|---|---|
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006330
The ClinicalTrials.gov registry entry for NCT00006330 describes a study currently listed as completed, categorized as NA. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Digoxin is the first listed.
NCT00006330 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006330 about?
NCT00006330 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn". Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent wi...
What is the current status of trial NCT00006330?
This trial is currently completed. It is a NA study.
What interventions are being tested in trial NCT00006330?
The interventions under investigation include: Digoxin (DRUG), Hawthorn (DRUG).
Who is sponsoring clinical trial NCT00006330?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 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.