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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]

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

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Mental Health

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]

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]

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]

Baseline
Posttreatment (at 1 week)

Secondary outcome [1]

Cardiovascular function (pulse pressure and augmentation index)

Timepoint [1]

Baseline
Posttreatment (1 week)

Secondary outcome [2]

Electroencephalogram (P300)

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Western Sydney

Address [1]

Campbelltown Campus - Narellan Road, Campbelltown, NSW, 2560

Country [1]

Australia

Primary sponsor type

University

Name

University of Western Sydney

Address

Campbelltown Campus - Narellan Road, Campbelltown, NSW, 2560

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Western Sydney Human Research Ethics Committee (EC00314)

Ethics committee address [1]

University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/07/2010

Ethics approval number [1]

H8253

Ethics committee name [2]

University of Western Sydney Biosafety and Radiation Ethics Committee

Ethics committee address [2]

University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

07/07/2010

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Associate Professor Dennis Chang

Address

University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797

Country

Australia

Phone

+61 2 4620 3920

Fax

d.chang@uws.edu.au

Contact person for scientific queries

Name

Associate Professor Dennis Chang

Address

University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW, 1797

Country

Australia

Phone

+61 2 4620 3920

Fax

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

Source	Title	Year of Publication	DOI
Embase	The effect of Sailuotong (SLT) on neurocognitive and cardiovascular function in healthy adults: A randomised, doubleblind, placebo controlled crossover pilot trial.	2016	https://dx.doi.org/10.1186/s12906-016-0989-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically