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 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.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ. of Michigan Medical Center

Ann Arbor, Michigan, 48109-0008, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digoxin

Drug

Hawthorn

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Registry information

Important dates

First posted: Oct 5, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed