Healthy
Conditions
Keywords
bio-availability, decursin, decursinol angelate, decursinol, subjects
Brief summary
This study is to investigate how human bodies absorb and metabolize two herbal drugs. The information is critical for drug development and could not be obtained from any other studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies indicated that AGN and decursin/DA were quite safe to animals and human.
Interventions
DIETARY_SUPPLEMENT800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Health subjects weighing between 50 to 91 kilograms (110 to 200 pounds) * Subjects 18 to 65 years of age * Subjects having normal hepatic, renal and bone marrow function as assessed by history, physical and clinical chemistry analysis
Exclusion criteria
* Subjects positive for HIV, HBV and HCV * Subjects with diabetes-due to length of fasting * Subjects regularly taking any kind of prescription medications * Subjects taking oral contraception, hormone-containing IUDs, contraception implants, or Depo medroxyprogesterone injections * Subjects taking any food or herbal supplements containing AGN (e.g. CognIQTM, D-Cursinol, Decursinol-50™, Ache Action™, Fast-Acting Joint Formula, EstroG-100™) within 30 days of the study. * Female subjects that are pregnant, \<6 months postpartum, or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb | 0 and 24 hours post-dose |
Countries
United States
Outcome results
None listed