fever platelet aggregation complementary medicine herbal medicine platelet aggregation pharmacokinetics
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18-45 years 2. Body Mass Index (BMI) in the range of 18-24 kg/m2 3. determined healthy by physical examination, assessment of drug abuse, medical history, and vital signs 4. Have normal or acceptable results for Complete Blood Count (CBC), Blood Urea Nitrogen (BUN), Serum Creatinine (Cr), Aspartate Amino Transminase (AST), Alanine Amino Transminase (ALT), Fasting Blood Sugar (FBS), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglyceride 5. Be willing to participate and signed the informed consent form
Exclusion criteria
Exclusion criteria: 1.Has history usage of other drugs, especially which can effect platelet aggregation e.g. aspirin, clopidogrel, ticlopidine 2.Has history of allergic reactions or allergy to drug especially paracetamol or NSAIDs 3.Has history of allergy reaction or allergy to AVS022 or one of its herbal components include Capparis micracantha , Clerodendrum indicum , Ficus racemosa , Harrisonia perforata., and Tiliacora triandra 4.Is regularly caffeine consumption (more than 1 time/week) and will consume it during the study period 5.Is regularly alcohol consumption (more than 1 time/week) or drug addict 6.Is a smoker or non smoker less than 14 days before enrollment 7.Is using supplements or vitamins within 14 days before enrollment and will use any of these during the study period 8.Is participation in other clinical studies within last 30 days 9.Is a pregnant woman or woman in breast feeding period or have positive pregnancy test 10.Has blood donation within last 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma metabolite profile 0, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours LC-MS | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of platelet aggregation 0, 3, 6, 24 hours after doses Light transmission aggregometry,Correlation of plasma metabolite profile and percentage of platelet aggregation 0, 3, 6, 24 hours after doses statistical correlation | — |
Countries
Thailand
Contacts
Mahidol University