Healthy volunteers: Llatelet aggregation for assessing the safety of the drug Healthy volunteers
Conditions
Interventions
Ya Hom Thep Pha Jit pills (250 mg each) and powder (150 g) were prepared the Manufacturing Unit of Herbal Medicines and Products, manufactured under GMP/PICs (Good Manufacturing Practices) quality c
Experimental Drug
Thai Herbal Ya Hom Thep Pha Jit formula
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females of Thai nationality are age equal to 18 years old. 2. No underlying medical conditions, or have stable, untreated conditions as deemed acceptable by the study physician. 3. Participants must be healthy, as confirmed by blood chemistry (AST, ALT, ALP, Creatinine), or have clinically insignificant abnormalities as determined by the study physician. 4. Body mass index (BMI) between 18.0 to 24.9 kilogram per square meter 5. Willingness to participate in the study and to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of using medications, herbal remedies, vitamins, and dietary supplements within the past 1 month prior to study enrollment. 2. A history of herbal allergic or pollen allergies. 3. A history of regular smoking, alcohol consumption, and/or consumption of aloholic beverages. 4. Pregnant or breastfeeding or have a positive urine pregnancy test. 5. Participants with a history of significant abnormal bleeding within the past 6 months, such as following trauma or surgery, or illnesses requiring blood transfusions. 6. Participants who have donated blood or experienced blood loss in the following quantities: equal to 50 mL (approximately 3 tablespoons) and less than 499 mL (approximately 33 tablespoons or approximately half a liter) within 30 days prior to study enrollment, or equal to 500 mL (approximately 33 tablespoons or approximately half a liter) within 56 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet aggregation Before dose and after dose at 3, 6, and 24 hours percentage of maximum light transmission | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event (AE) Report Before dose and after dose at 3, 6, and 24 hours Event Record | — |
Countries
Thailand
Contacts
Public Contactjakkarin wattanakittikul
Mahidol University
Outcome results
None listed