Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006330
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-10-04
Brief Title:
Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 0125 mg - 025 mgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000042 | NIH | None | httpsreporternihgovquickSearchM01RR000042 |