Study of the effect of black garlic on immunity and coagulation in healthy volunteers
- Conditions
- Immunity
- Registration Number
- TCTR20210610001
- Lead Sponsor
- Department of Pharmacology, Faculty of Medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
Male and female Healthy volunteer aged 20-45 years;
No significant underlying disease;
All patients will be informed both verbally and in writing of the possible risks and adverse events which may occur during the study and must sign the written consent forms to participate in the study.
Abnormal finding after physical examination
BMI more than or equal to 25 kg/m2
Clinically significant abnormalities in blood chemistry and hematology:
oHemoglobin < 10 g/dL
oWhite blood cells < 4,000 per cu. mm.
oPlatelets < 100,000 per cu. mm.
oAlanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase more than 2 times the upper limit of normal
oBlood urea nitrogen (BUN) more than 20 mg/dL, creatinine more than 1.5 times the upper limit of normal
oAbnormal urine examination
oProthrombin time (PT) more than 13.0 sec, international normalized ratio (INR) more than 5, or partial thromboplastin time (PTT) more than 38.9 sec
Unable to participate throughout the study period
Have a history of hypersensitivity to garlic or black garlic
Smoking
Pregnant or lactating;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cytokines Day 0, 1, 28, 56 ELISA,White blood cells Day 0, 1, 28, 56 Flow cytometry
- Secondary Outcome Measures
Name Time Method Platelet aggregation Day 0, 28, 56 Platelet aggregometry,Coagulation Day 0, 28, 56 PT, PTT, INR,Safety Day 0, 14, 28, 56 CBC, BUN, Cr, LFT, U/A,VASP Day 0, 28, 56 VASP phosphorylation assay