Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000849099
Ethics application status
Approved
Date submitted
5/10/2010
Date registered
8/10/2010
Date last updated
27/07/2020
Date data sharing statement initially provided
27/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the acute cognitive and neurocognitive effects of Panax Quinquefolius (American Ginseng) in middle aged volunteers.
Scientific title
A study of the acute cognitive and neurocognitive effects of Panax Quinquefolius in healthy middle aged volunteers.
Secondary ID [1] 252844 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 243885 0
Glucoregulatory Function 243886 0
Condition category
Condition code
Alternative and Complementary Medicine 252060 252060 0 0
Other alternative and complementary medicine
Mental Health 252061 252061 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of 200mg Panax Quinquefolius ( 11.65% saponin content; Rb1 (5.68%), Re (2.05%), Rc (1.86%), Rd (1.47%), Rb2 (.029%), Rg1 (.027%)) administered orally (capsule form). Participants have a 1 week wash-out between the active treatment and placebo.
Intervention code [1] 241317 0
Prevention
Intervention code [2] 257363 0
Behaviour
Comparator / control treatment
Single dose of placebo (Avicel – an inert plant cellulose fibre) administered orally (capsule form). Participants have a 1 week wash-out between the active treatment and placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 252959 0
Cognitive functioning - measured using Cognitive Drug Research (CDR) battery and the Cognitive Demand Battery (CDB).
Timepoint [1] 252959 0
Baseline and 1, 3 and 6 hours Post-dose
Primary outcome [2] 252960 0
Speed of information processing - measured by Steady State Topography (SST) latency.
Timepoint [2] 252960 0
6.5 hours post-dose
Secondary outcome [1] 257698 0
Mood measured using Bond-Lader Visual Analogue Scales, the State-Trait Anxiety Inventory (STAI) and the Profile of Mood States (POMS)
Timepoint [1] 257698 0
Baseline and 1, 3 and 6 hours post-dose

Eligibility
Key inclusion criteria
1. Healthy non-smoking males and females aged between 40 and 60 years.
2. No history of anxiety, depression, psychiatric disorders confirmed using Depression Anxiety Stress Scale) or epilepsy
3. No history of / do not currently suffer from heart disease or high blood pressure or diabetes
4. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study
5. Not taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
6. No health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
7. Absence of pregnancy (confirmed using a pregnancy test)
8. Are willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
9. Are willing to provide small finger prick blood samples throughout the testing phases
10. Are not photosensitive (a sensitivity to visual stimuli, such as flashing lights, bright lights, light presented to full visual field, or static or moving patterns of light and dark stripes)
11. Absence of cognitive decline and a score > 24 on the mini mental state examination and within normal ranges on CDR battery
12. Understand the rating scales and computer tests (as judged by the study coordinator)
13. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
14. Have a fasting blood glucose <6.1mmol/l
15. Systolic blood pressure withing the normal range (91-139mmHg) and diastolic blood pressure within the normal range (61-89mmHg)
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoker, hypersensitivity to investigational product, anxiety, depression, psychiatric disorder, epilepsy, heart disease, high blood pressure, diabetes, taking medications, health conditions that would effect food metabolism, pregnant/breast feeding, unable to commit to testing days, photo sensitive, not willing to provide finger prick blood samples, use of over the counter herbal supplements and dietary supplements 4 weeks prior to the study, history of head injury/stroke, alcoholism, clinically relevant abnormalities in medical history.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through advertising in local newspapers and community bulletin boards. They will be screened over the phone to ensure they are able to participate in the study. Participants will be randomly allocated to a treatment one or two for the first active test session (after the practice day) and will then receive the corresponding treatment in the following active test session. Randomization of participants to treatment groups will be determined by random allocation. All 50 participants will be assigned a treatment order (either treatment ‘a’ then ‘b’, or ‘b’ then ‘a’) using a computerised random number generator. Eligible, recruited participants will be assigned a participant number. The treatment number that has been placed next to the participant’s number will be the allocated treatment order for that individual.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will determine whether participants take treatment a or b on their first testing day. This will be performed by a disinterested third party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This will be a randomized, double-blind, placebo-controlled, within-subjects design study in which all participants will be administered both the active and inert capsules on separated testing sessions (the order of which will be randomized) after controlling for baseline scores the test scores achieved after treatment will be compared to these scores achieved following placebo.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/06/2010
Actual
22/06/2010
Date of last participant enrolment
Anticipated
Actual
1/09/2010
Date of last data collection
Anticipated
Actual
14/09/2010
Sample size
Target
50
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243769 0
Commercial sector/Industry
Name [1] 243769 0
Naturex
Country [1] 243769 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Naturex
Address
375 Huyler Street
South Hackensack, NJ 07606
Country
United States of America
Secondary sponsor category [1] 237128 0
None
Name [1] 237128 0
Address [1] 237128 0
Country [1] 237128 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243899 0
Swinburne Univeristy Human Research Ethics Committee
Ethics committee address [1] 243899 0
Ethics committee country [1] 243899 0
Australia
Date submitted for ethics approval [1] 243899 0
Approval date [1] 243899 0
25/03/2010
Ethics approval number [1] 243899 0
SUHREC 0708/155

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30310 0
Address 30310 0
Country 30310 0
Phone 30310 0
Fax 30310 0
Email 30310 0
Contact person for public queries
Name 13557 0
Prof Andrew Scholey
Address 13557 0
400 Burwood Rd
Hawthorn VIC 3122
Country 13557 0
Australia
Phone 13557 0
+613 9214 8932
Fax 13557 0
Email 13557 0
[email protected]
Contact person for scientific queries
Name 4485 0
Prof Andrew Scholey
Address 4485 0
400 Burwood Rd
Hawthorn VIC 3122
Country 4485 0
Australia
Phone 4485 0
+613 9214 8932
Fax 4485 0
Email 4485 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproved working memory performance following administration of a single dose of American ginseng (Panax quinquefolius L.) to healthy middle-age adults.2015https://dx.doi.org/10.1002/hup.2463
EmbaseEffects of Panax quinquefolius (American ginseng) on the steady state visually evoked potential during cognitive performance.2020https://dx.doi.org/10.1002/hup.2756
N.B. These documents automatically identified may not have been verified by the study sponsor.