Effect of Herbal Products on Platelet Function and Clotting
Condition: Platelet Function Test
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Curcuma longa; Angelica sinensis; Siwu Tang; Aspirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Curcuma longa in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.; Angelicae sinensis in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.; TCM formulation "Siwu Tang" consisting of 4 herbs ( Ligustici chuangxiong, Angelicae sinensis, Rehmanniae praeparata and Paeoniae alba) in tablet form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.; Aspirin (enteric-coated) at 100mg daily will be given one of the actual herb or placebo herb, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
Intervention MeSH terms: Aspirin; Turmeric extract
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment