RecruitingPhase 2ACTRN12610000947000

Effects of a standardised herbal formula Wei Nao Kang(WNK) on neurocognitive function in healthy volunteers: a pilot study


Sponsor

University of Western Sydney

Enrollment

16 participants

Start Date

Sep 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 22 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a Chinese herbal formula called Wei Nao Kang (WNK) — containing extracts of ginseng, ginkgo biloba, and saffron — can improve thinking ability and heart-related measurements in healthy adults. Participants will take either WNK or a dummy pill for two weeks, then switch after a 10-day break. Thinking skills will be tested before and after each treatment. You may be eligible if: - You are between 22 and 75 years old - You are a non-smoker - Your body weight is within 15% of the ideal range for your height - Your MMSE (memory test) score is 21 or above You may NOT be eligible if: - You are pregnant - You have a history of allergies - You have serious gut, lung, or psychiatric conditions - You have diabetes - You currently use medications, especially blood thinners or cognitive enhancers - You have taken part in a clinical trial or donated blood in the past 30 days - You currently take any herbal or pharmaceutical cognitive enhancing supplements Talk to your doctor about whether this trial might be right for you.

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Interventions

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

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


Locations(1)

Australia

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ACTRN12610000947000