Platelet Function Test Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-controlled Crossover Study on the Effect of Commonly Used Herbal Products on Platelet Function and Coagulation Profile of Healthy Volunteers
This is a research study on the effect of some commonly used "blood activating" herbal products on platelet function and coagulation profile, ie whether it causes an increase in bleeding tendency, either used alone or in combination with Aspirin which is a commonly used anti-platelet drug.
This study is being conducted because there has not been any proper studies to provide
evidence that these commonly used "blood activating" herbal preparations can in fact affect
blood clotting by interfering with platelet function or clotting mechanism and potentiate
the antiplatelet activity of Aspirin. These are assumptions based on TCM theory, laboratory
experiments and animal studies but have led to the general statement in medical literature
that these herbs increases bleeding risk in patients taking Aspirin or any other
anti-platelet drugs. This has resulted in advice that these herbal products should not be
taken by patients on Aspirin, which is a common drug taken by many patients. We hope to
prove or disprove this theoretical concern by measurement of platelet and clotting function
in healthy volunteers before and after taking the herbal product, alone and in combination
with Aspirin. This will help to answer the question of whether it is safe for patients to
take these common "blood -activating " herbs alone or together with Aspirin.
Healthy volunteers will be consecutively enrolled into 3 arms, each studying one herbal
product for 25 volunteers. The design involves taking all 3 of the following combinations:
aspirin + placebo, herb + placebo, aspirin + herb, each for a 3-week period, in a randomized
order, with 2 weeks of wash-out in between each 3-week period. Platelet function and
coagulation profile will be assayed
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment