Skip to main content
OpenTrials
Completed

NCT Number: NCT02114957

Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center

Amarillo, Texas, 79106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0

Dietary Supplement

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose

Secondary outcomes

  1. vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb

    Time frame: 0 and 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women

Important dates

Study start
2013
Primary completion
2013
First posted
Apr 15, 2014
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.