Effect of Herbal Products on Platelet Function and Clotting

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Singapore General Hospital
• Collaborator: Singhealth Foundation
• Treatments: Aspirin; Turmeric extract

Criteria

Inclusion Criteria:

1. Males and females between the ages of 18 and 70 years.

2. Healthy by medical history and physical exam.

3. Laboratory values within established guidelines for participation in clinical studies:

AST less than or equal to 2 times the ULN; SCr less than or equal to ULN; FBC showing normal Hb; WBC and platelet count; normal aPTT/PT

4. Negative urine pregnancy test for females of child-bearing potential.

5. Females of child-bearing potential who are able and willing to practice abstinence or use non-hormonal effective methods of birth control during the study, such as condoms or diaphragms.

Exclusion Criteria:

1. 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

2. Inability to obtain venous access for blood sample collection.

3. The presence of any of the following significant medical conditions:

1. Diabetes mellitus poorly controlled or requiring insulin

2. Hypertension poorly controlled

3. Cardiac disease : heart failure, arrhythmia poorly controlled

4. Renal disease,

5. Hepatic impairment

6. Bleeding disorders including thrombocytopenia and coagulopathy, either congenital or acquired

7. Peptic ulcer disease

8. Psychiatric illnesses that may interfere with the subject's ability to participate in the study, or any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the investigators.

4. Plans for elective surgery during the investigation or within 2 weeks following completion of the study.

5. Positive urine pregnancy test or breastfeeding female.

6. The presence of persistent diarrhea or malabsorption that would interfere with the subject's ability to absorb drugs.

7. Drug or alcohol abuse that may impair safety or adherence (more than 3 alcoholic drinks per day, on a daily basis).

8. History of intolerance or allergic reaction to aspirin or any NSAIDS

9. Pregnancy or lactation