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| Name | Class |
|---|---|
| Singhealth Foundation | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angelica sinensis | Active Comparator | Angelica 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. |
|
| Curcuma longa | Active Comparator | 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. |
|
| Siwu Tang | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcuma longa | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| platelet function test and coagulation profile | Platelet function test and coagulation profile ( aPTT/PT) will be done at baseline and after each phase of 3 weeks of Herb/aspirin or their placebo | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant therapy (chronic or intermittent) with herbal drugs, aspirin, any other anti-platelet agents, non-steroidal anti-inflammatory medications or warfarin from 14 days prior to study participation and throughout the study period
Inability to obtain venous access for blood sample collection.
The presence of any of the following significant medical conditions:
Plans for elective surgery during the investigation or within 2 weeks following completion of the study.
Positive urine pregnancy test or breastfeeding female.
The presence of persistent diarrhea or malabsorption that would interfere with the subject's ability to absorb drugs.
Drug or alcohol abuse that may impair safety or adherence (more than 3 alcoholic drinks per day, on a daily basis).
History of intolerance or allergic reaction to aspirin or any NSAIDS
Pregnancy or lactation
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| Name | Affiliation | Role |
|---|---|---|
| Yeh-Ching Linn, MBBS, MRCP | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | 169856 | Singapore |
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| ID | Term |
|---|---|
| C012596 | turmeric extract |
| C044613 | angelicae sinensis extract |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Angelica sinensis | Drug | 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. |
|
| Siwu Tang | Drug | 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 | Drug | 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. |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |