HealthyEarly Phase 1NCT02114957
Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)
A Early Phase 1 study testing 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0 in people with Healthy, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center
Amarillo, Texas, 79106
About this study
Official title: Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women
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.
- Conditions
- Healthy
- Being tested
- 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0
- Keywords
- bio-availability, decursin, decursinol angelate, decursinol, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| study herb | Experimental | Not described Receives: Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol
Measured: 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
Measured: 0 and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinhui Zhang, Ph.D, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114957
- Sponsor's protocol ID
- A12-3742
- Status last verified
- Apr 2014
- First submitted
- 11 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang J, Li L, Hale TW, Chee W, Xing C, Jiang C, Lu J. Single oral dose pharmacokinetics of decursin and decursinol angelate in healthy adult men and women. PLoS One. 2015 Feb 19;10(2):e0114992. doi: 10.1371/journal.pone.0114992. eCollection 2015.
PubMed 25695490
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women
- ClinicalTrials.gov ID
- NCT02114957
- Acronym / sponsor ID
- A12-3742
- Conditions
- Healthy
- Keywords
- bio-availability, decursin, decursinol angelate, decursinol, subjects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study herb | Experimental | Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0 | Dietary supplement | study herb |
Primary outcome
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
1 secondary outcome
vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb
Time frame: 0 and 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Derived from this study: PubMed 25695490Zhang J, Li L, Hale TW, Chee W, Xing C, Jiang C, Lu J. Single oral dose pharmacokinetics of decursin and decursinol angelate in healthy adult men and women. PLoS One. 2015 Feb 19;10(2):e0114992. doi: 10.1371/journal.pone.0114992. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhui Zhang, Ph.D principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0 in people with Healthy, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.