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Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006330
Recruitment Status : Completed
First Posted : October 5, 2000
Last Update Posted : June 24, 2005
Information provided by:
National Center for Research Resources (NCRR)

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 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.

Condition or disease Intervention/treatment Phase
Heart Diseases Drug: Digoxin Drug: Hawthorn Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006330

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United States, Michigan
Univ. of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0008
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Layout table for additonal information Identifier: NCT00006330    
Other Study ID Numbers: NCRR-M01RR00042-1693
M01RR000042 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001
Keywords provided by National Center for Research Resources (NCRR):
Effect modifiers (Epidemiology)
Drug Interaction
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs