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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: Completed NA study, sponsored by National Center for Research Resources (NCRR).
NCT00006330 is a NA study that has completed, run by National Center for Research Resources (NCRR). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00006330 record still lists
NCT00006330 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 2 interventions - of which Digoxin is the first listed.
NCT00006330 does not publish any study locations in the registry export this page uses.
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.