The pilot study of plasma metabolite profile after administration of Ayurved Siriraj Herbal Recipe Ha-Rak (AVS022) in relation to platelet aggregation in individual healthy volunteer.

Phase 1

• Conditions: feverplatelet aggregation; complementary medicine; herbal medicine; platelet aggregation; pharmacokinetics

• Registration Number: TCTR20150724002
• Lead Sponsor: Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-24
• Study Completion: 2015-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 5

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified