CompletedPhase 1ACTRN12607000054415

Interactions between herbal medicines and the anticoagulant warfarin

Pharmacokinetic and pharmacodynamic interactions between herbal medicines (cranberry, garlic, echinacea, policosonal, fish oil, CoEnzyme Q10, Soy, feverfew, milk thistle and evening primrose oil) and the anticoagulant warfarin - Randomised clinical trials in healthy male subjects


Sponsor

Prof Andrew McLachlan

Enrollment

60 participants

Start Date

Jan 24, 2005

Study Type

Interventional

Conditions

Summary

This study will explore the clinical significane of interactions between commonly used herbal medicines with the anti-coagulant warfarin. In total 5 independent three- treatment cross over randomnised clinical trials will be conducted with similar study design. In each trial 2 herbs will be studied.


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at: Interactions between herbal medicines and the anticoagulant warfarin. It is open to men only, aged 18 to 50. To take part, you generally need: Healthy subjects not taking other medicines including any supplements, who are non-smokers. There are also some health conditions and factors that may prevent you from joining.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In each 3-treatment cross over clinical trial 2 herbal medicine will be studied. Dosage of the herbal medicines mentioned here are based upon the current information and subject to change in accordenc

In each 3-treatment cross over clinical trial 2 herbal medicine will be studied. Dosage of the herbal medicines mentioned here are based upon the current information and subject to change in accordence with the latest clinical evidence which will be decided prior to each clinical trial. Variations in pharmacokinetics and pharmacodynamics of warfarin will be compared when single dose of 25 mg warfarin given alone orally (control) and when single dose of 25 mg warfarin given after 2 weeks of pre-treatment with each herbal medicine administered orally (intervention). Herbal medicines intake will be continued for one more week after warfarin administration. In total 10 herbs will be studied in 5 clinical trials. List of the proposed herbs are cranberry (6 X 500mg capsules per day of General Nutrition Corporation (GNC) cranberry juice concentrate capsules), garlic (equivalent to 4 g of fresh garlic), echinacea (4 X 1.27g tablets daily of Medi herb echinacea premium tablets), policosonal (20 mg daily), fish oil (4 g per day), CoEnzyme Q10 (50 mg per day), Soy (3.5 mg per day of phospholipids) , feverfew (100 mg of powdered feverfew daily), Milk thistle (250 mg daily of silymarin) and evening primrose oil (300 mg daily of fixed oil) .


Locations(1)

Australia

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ACTRN12607000054415