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Trial registered on ANZCTR
Registration number
ACTRN12618001850268
Ethics application status
Approved
Date submitted
9/11/2018
Date registered
14/11/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of the effects of a herbal medicine on cognitive function associated with age-related decline in older adults
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Scientific title
An open label study into the effects of a herbal medicine on cognitive function, quality of life and specific biomarkers associated with age-related decline in older adults
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Secondary ID [1]
296567
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognitive function
310352
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Elderly
310387
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Condition category
Condition code
Alternative and Complementary Medicine
309079
309079
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0
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Other alternative and complementary medicine
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Mental Health
309081
309081
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
MediHerb PhytoRegenex (AUST L 225226) tablets contain extracts of Ginseng (Panax ginseng) 250 mg, Giant Knotweed (Fallopia japonica) 8.0 g, St Mary’s Thistle (Silybum marianum) 4.2 g, Ginkgo (Ginkgo biloba) 1.5 g and Grape Seed (Vitis vinifera) 4.8 g. Participants will take 4 tablets per day (2 tablets morning and 2 tablets evening) orally. The tablets will be supplied in clear brown glass containers with 60 tablets per container. The bottle will be clearly labelled as clinical trial medication with all necessary clinical trial information including contact details. Trial participation lasts for 84 days. Participants will be provided with sufficient MediHerb PhytoRegenex tablets at baseline (day 0) visit to last for 6 weeks, and an appointment will be made to visit on day 42. Study intervention use will be recorded, and any returned medication will be counted as a measure of compliance. At day 42 participants will be provided with sufficient MediHerb PhytoRegenex tablets at day 42 visit to last for 6 weeks, and an appointment will be made to visit on day 84. Study intervention use will be recorded, and any returned medication will be counted as a measure of compliance. Any participant with less than 60% compliance overall will be excluded from analysis. Follow up phone calls every 2 weeks (at week 2, 4, 8 and 10) will be used to monitor adherence. The last day of taking tablets will be on day 84, the day of the last visit. The last visit can occur (+/- 2) days depending on the availability of the participant.
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Intervention code [1]
312869
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Prevention
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Cognition tests (composite primary outcome): CANTAB core cognition test battery (Paired Associates Learning, Reaction Time, Spatial Working Memory)
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Assessment method [1]
308048
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Timepoint [1]
308048
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Screening visit (day -5) – familiarize CANTAB cognition software
CANTAB cognition tests conducted at baseline (day 0); day 42 and day 84 (primary endpoint)
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Secondary outcome [1]
353831
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Biomarkers (composite secondary outcome): Serum assays will be performed for all biomarkers.
Interleukin-6 (IL-6), Tumor necrosis factor alpha (TNF-a), High sensitivity C-reactive protein (hs-CRP), Glutathione (GSH), Brain derived neurotrophic factor (BDNF), Dehydroepiandrosterone sulphate (DHEAS), Glycosylated haemoglobin (HbA1c), Fasting blood glucose, Insulin, IGF-1, 8-iso prostaglandin F2a, 8-hydroxy-2' -deoxyguanosine (8-OHdG)
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Assessment method [1]
353831
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Timepoint [1]
353831
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Baseline (day 0) and day 84
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Secondary outcome [2]
353832
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Quality of Life using Short form -12 (SF-12)
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Assessment method [2]
353832
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Timepoint [2]
353832
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Baseline (day 0); day 42 and day 84
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Secondary outcome [3]
353833
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Blood pressure measured using a digital blood pressure monitor.
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Assessment method [3]
353833
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Timepoint [3]
353833
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Baseline (day 0); day 42 and day 84
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Eligibility
Key inclusion criteria
1) Aged 50-75 years
2) In good health (no serious current illness)
3) If taking any allowed medication(s) or supplement, must be stable for greater than or equal to 2 months
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Minimum age
50
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1) Individuals who are diagnosed with a significant chronic disease, including kidney, liver, neurological disease, autoimmune disease, Diabetes Type 1 or medicated for Type 2, or cancer
2) Hypertension grade 2 or above (>160 systolic and/or >100 diastolic)
3) Individuals taking warfarin or other anti-coagulation medication, antiretroviral, immunosuppressant, anti-psychotic or anti-epileptic medication
4) Currently taking anti-inflammatory medicines (including specific complementary e.g. curcumin and conventional medicines e.g. NSAIDs, corticosteroids, antihistamines, immunosupressants and antibiotics)
5) Currently taking herbal medicines
6) Individuals who have commenced a new conventional or complementary medication in the last 2 months
7) Smokers or currently on nicotine therapy
8) Known allergy to any of the ingredients in the formulation
9) Individuals that have participated in another clinical trial in the last 30 days
10) Current or recent history of stimulant use/abuse
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
11/07/2018
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Date of last participant enrolment
Anticipated
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Actual
7/11/2018
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Date of last data collection
Anticipated
30/01/2019
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Actual
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Sample size
Target
20
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
301144
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Commercial sector/Industry
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Name [1]
301144
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Integria Healthcare Pty Ltd
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Address [1]
301144
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Gallans Rd
Ballina
NSW
2478
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Country [1]
301144
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Integria Healthcare Pty Ltd
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Address
Gallans Rd
Ballina
NSW
2478
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Country
Australia
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Secondary sponsor category [1]
300765
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None
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Name [1]
300765
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Address [1]
300765
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Country [1]
300765
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301894
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Griffith University Human Research Ethics Committee
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Ethics committee address [1]
301894
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170 Kessels Road
Nathan
QLD 4111
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Ethics committee country [1]
301894
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Australia
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Date submitted for ethics approval [1]
301894
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Approval date [1]
301894
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31/05/2018
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Ethics approval number [1]
301894
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2018/419
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Summary
Brief summary
This study will evaluate the effect of MH-PR on a range of biomarkers and cognitive tests associated with age-related decline. Additionally, this study aims to evaluate additional health benefit through measuring change in QOL and blood pressure.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Evelin Tiralongo
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Address
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Griffith University Clinical Trial Unit,
Level 4, Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport, QLD 4215
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Country
88462
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Australia
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Phone
88462
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+61 (0) 7 5678 0366
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Fax
88462
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Email
88462
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[email protected]
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Contact person for public queries
Name
88463
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A/Prof Evelin Tiralongo
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Address
88463
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Griffith University Clinical Trial Unit,
Level 4, Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport, QLD 4215
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Country
88463
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Australia
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Phone
88463
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+61 (0) 7 5678 0366
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Fax
88463
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Email
88463
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[email protected]
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Contact person for scientific queries
Name
88464
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A/Prof Evelin Tiralongo
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Address
88464
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Griffith University Clinical Trial Unit,
Level 4, Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport, QLD 4215
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Country
88464
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Australia
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Phone
88464
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+61 (0) 7 5678 0366
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Fax
88464
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Email
88464
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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