- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006330
Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
June 23, 2005 updated by: National Center for Research Resources (NCRR)
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109-0008
- Univ. of Michigan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult
- Not regularly taking any prescription or non-prescription medications (including natural products or supplements) and is willing to avoid all medications other than the study drugs during the study period.
- Willing to avoid drinking any alcohol throughout the study period.
- Does not currently smoke and is willing to avoid smoking during the study period.
- Willing to adhere to dietary restrictions as required during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 4, 2000
First Submitted That Met QC Criteria
October 4, 2000
First Posted (Estimate)
October 5, 2000
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
November 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCRR-M01RR00042-1693
- M01RR000042 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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