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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
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
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
Secondary ID [1] 296567 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 310352 0
Elderly 310387 0
Condition category
Condition code
Alternative and Complementary Medicine 309079 309079 0 0
Other alternative and complementary medicine
Mental Health 309081 309081 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312869 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308048 0
Cognition tests (composite primary outcome): CANTAB core cognition test battery (Paired Associates Learning, Reaction Time, Spatial Working Memory)
Timepoint [1] 308048 0
Screening visit (day -5) – familiarize CANTAB cognition software
CANTAB cognition tests conducted at baseline (day 0); day 42 and day 84 (primary endpoint)
Secondary outcome [1] 353831 0
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)
Timepoint [1] 353831 0
Baseline (day 0) and day 84
Secondary outcome [2] 353832 0
Quality of Life using Short form -12 (SF-12)
Timepoint [2] 353832 0
Baseline (day 0); day 42 and day 84
Secondary outcome [3] 353833 0
Blood pressure measured using a digital blood pressure monitor.
Timepoint [3] 353833 0
Baseline (day 0); day 42 and day 84

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
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
11/07/2018
Date of last participant enrolment
Anticipated
Actual
7/11/2018
Date of last data collection
Anticipated
30/01/2019
Actual
Sample size
Target
20
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 301144 0
Commercial sector/Industry
Name [1] 301144 0
Integria Healthcare Pty Ltd
Country [1] 301144 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integria Healthcare Pty Ltd
Address
Gallans Rd
Ballina
NSW
2478
Country
Australia
Secondary sponsor category [1] 300765 0
None
Name [1] 300765 0
Address [1] 300765 0
Country [1] 300765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301894 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 301894 0
Ethics committee country [1] 301894 0
Australia
Date submitted for ethics approval [1] 301894 0
Approval date [1] 301894 0
31/05/2018
Ethics approval number [1] 301894 0
2018/419

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

Contacts
Principal investigator
Name 88462 0
A/Prof Evelin Tiralongo
Address 88462 0
Griffith University Clinical Trial Unit,
Level 4, Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport, QLD 4215
Country 88462 0
Australia
Phone 88462 0
+61 (0) 7 5678 0366
Fax 88462 0
Email 88462 0
[email protected]
Contact person for public queries
Name 88463 0
Evelin Tiralongo
Address 88463 0
Griffith University Clinical Trial Unit,
Level 4, Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport, QLD 4215
Country 88463 0
Australia
Phone 88463 0
+61 (0) 7 5678 0366
Fax 88463 0
Email 88463 0
[email protected]
Contact person for scientific queries
Name 88464 0
Evelin Tiralongo
Address 88464 0
Griffith University Clinical Trial Unit,
Level 4, Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport, QLD 4215
Country 88464 0
Australia
Phone 88464 0
+61 (0) 7 5678 0366
Fax 88464 0
Email 88464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.