Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000947000
Ethics application status
Approved
Date submitted
28/09/2010
Date registered
5/11/2010
Date last updated
25/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a standardised herbal formula Wei Nao Kang(WNK) on neurocognitive function in healthy volunteers: a pilot study
Scientific title
Effects of a standardised herbal formula Wei Nao Kang(WNK) on neurocognitive function in healthy volunteers: a pilot study
Secondary ID [1] 252623 0
Nil
Universal Trial Number (UTN)
U1111-1116-8074
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocognitive function in healthy individuals 258116 0
Condition category
Condition code
Alternative and Complementary Medicine 258292 258292 0 0
Herbal remedies
Mental Health 258621 258621 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Wei Nao Kang (WNK) now known as Sai Luo Tong is a herbal formulation containing extracts of Panax ginseng, Ginkgo biloba and Crocus sativus. Participants will receive 120mg/day in the form of an oral capsule for one week. The regimen inolves one 60mg oral capsule taken morning and evening each day.

There will be a 7 day washout period
Intervention code [1] 257135 0
Treatment: Drugs
Comparator / control treatment
Placebo comprising of a matched oral capusle taken morning and evening for one week.
Control group
Placebo

Outcomes
Primary outcome [1] 259143 0
Cognitive performance; simple reaction time, word recall, face recall, picture recall, spatial working memory, sustained attention which form part of the Compass test battery.
Timepoint [1] 259143 0
Baseline
Posttreatment (at 1 week)
Secondary outcome [1] 265466 0
Cardiovascular function (pulse pressure and augmentation index)
Timepoint [1] 265466 0
Baseline
Posttreatment (1 week)
Secondary outcome [2] 266038 0
Electroencephalogram (P300)
Timepoint [2] 266038 0
Baseline
Posttreatment (1 week)

Eligibility
Key inclusion criteria
-Age 22 to 75 years old
-Non-smoker
-Body weight not more than 15% of the ideal weight range for the subject’s height and frame (< 25 kg/m2) as in Ciba Geigy tables
-Mini Mental State Exam (MMSE) score of 21 or greater
Minimum age
22 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Pregnant women
-History of allergies
-Serious gastrointestinal disorders such as peptic ulcers
-History of asthma, bronchitis, or other serious pulmonary disorders
-History of drug or alcohol abuse
-Use of medication (in particular anti-coagulants and cognitive enhancers), participation in a clinical trial for an experimental drug, or blood donation within the last 30 days before the study
-Diabetes
-Diagnosed psychiatric disorders
-Use of any cognitive enhancing substances, either herbal or pharmaceutical
-Any significant abnormality, on laboratory tests including full blood count, liver, and renal test, as judged by a medically trained professional
-Any other condition judged by the physician that would place the volunteer in a risk category for the study

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)
Subjects will be contacted via phone or email to confirm availability as well as under a phone screening checklist which covers major inclusion/exclusion criteria. Following confirmation of their tentative eligibility, participants will be sent a participant information sheet and an appointment sheet detailing when their first screening appointment will take place via email or post.
At the beginning of the screening appointment, the attending researcher will brief the participant on the details of the trial, run through the Participant Information Sheet (PIS) and ask if they have any questions. Following this informed consent will be obtained from the participant before continuing with the screening process. The screening procedure will involve a physical examination by a medically trained professional and if the participant is over 50 years of age they will be required to undergo a blood test. Blood samples will be taken and analysed at a Douglas Hanley Moir pathology laboratory. Any significant abnormality on any of the laboratory tests as judged by a medically trained professional will preclude participation in the trial.
Once full eligilbility has been confirmed participants will be given an identification number. This number is not randomly assigned to participants however each number has already been randomly assigned to either the initial intervention or placebo group via a computer randomisation package conducted externally to the research team by a Research Program Coordinator within CompleMED.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of randomisation will be computer generated in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257724 0
University
Name [1] 257724 0
University of Western Sydney
Country [1] 257724 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Campbelltown Campus - Narellan Road, Campbelltown, NSW, 2560
Country
Australia
Secondary sponsor category [1] 256940 0
None
Name [1] 256940 0
Address [1] 256940 0
Country [1] 256940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259773 0
University of Western Sydney Human Research Ethics Committee (EC00314)
Ethics committee address [1] 259773 0
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797
Ethics committee country [1] 259773 0
Australia
Date submitted for ethics approval [1] 259773 0
Approval date [1] 259773 0
02/07/2010
Ethics approval number [1] 259773 0
H8253
Ethics committee name [2] 259775 0
University of Western Sydney Biosafety and Radiation Ethics Committee
Ethics committee address [2] 259775 0
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797
Ethics committee country [2] 259775 0
Australia
Date submitted for ethics approval [2] 259775 0
Approval date [2] 259775 0
07/07/2010
Ethics approval number [2] 259775 0
B8292

Summary
Brief summary
The aging population in Australia is growing and associated age-related cognitive impairment is also increasing. Cognitive impairment however is not limited to the domain of neurodegenerative diseases such as dementia and can affect otherwise healthy individuals. Current treatment interventions for healthy individuals with cognitive impairment are somewhat limited, however Chinese Herbal Medicine (CHM) typically uses various combinations of herbal products to treat illnesses and improve the quality of life in both healthy and pathological populations. The CHM formulation, Wei-Nao-Kang (WNK), consisting of extracts from Panax ginseng, Ginkgo biloba and Crocus sativus. These herbs are amongst some of the most widely used plant based medicinal products currently available on the market today. Each of these herbs has either shown, or been implicated in, cognitive and cardiovascular enhancing effects when administered individually in healthy and/or pathological populations. Although early evidence exists to demonstrate that the ginseng/ginkgo combination has synergistic effects on cognitive functions, very few studies have investigated the combined effects of these herbal products.
This study aims to determine the possible cognitive and cardiovascular benefits of the WNK formulation in a cohort of healthy volunteers to further expand on the body of research surrounding this CHM formulation.
This study will employ a randomised, placebo controlled, double-blinded crossover design spanning a period of three weeks. Fifteen (22-75 years) healthy volunteers will be recruited and randomly assigned to receive treatments of WNK formulation or placebo over two weeks with a 10 day washout period between each week. Participants will be tested before and after each of the interventions to assess their cognitive and cardiovascular changes. The primary outcome measure is the Comppas test battery, which assesses various domains of cognitive function. Secondary outcome measures include an electroencephalography (EEG) recording while being exposed to a visual stimulus paradigm designed to elicit event related potentials (ERP), and cardiovascular measurements including pulse velocity waveforms and electrocardiography (ECG) recordings.
Once the trial is completed, participants will be debriefed and asked to complete a short survey for confirmation of compliance and successful blinding. Following this, results from the Compass, EEG, pulse velocity waveforms and ECG will be analysed and prepared for publication.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31598 0
Address 31598 0
Country 31598 0
Phone 31598 0
Fax 31598 0
Email 31598 0
Contact person for public queries
Name 14845 0
Associate Professor Dennis Chang
Address 14845 0
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797
Country 14845 0
Australia
Phone 14845 0
+61 2 4620 3920
Fax 14845 0
Email 14845 0
d.chang@uws.edu.au
Contact person for scientific queries
Name 5773 0
Associate Professor Dennis Chang
Address 5773 0
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797
Country 5773 0
Australia
Phone 5773 0
+61 2 4620 3920
Fax 5773 0
Email 5773 0
d.chang@uws.edu.au

No information has been provided regarding IPD availability


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
EmbaseThe effect of Sailuotong (SLT) on neurocognitive and cardiovascular function in healthy adults: A randomised, doubleblind, placebo controlled crossover pilot trial.2016https://dx.doi.org/10.1186/s12906-016-0989-0
N.B. These documents automatically identified may not have been verified by the study sponsor.