Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000107022
Ethics application status
Approved
Date submitted
26/01/2010
Date registered
2/02/2010
Date last updated
9/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of an herbal supplement on memory in people who have had a mild traumatic brain injury
Scientific title
Enzogenol supplementation for improving cognitive function in post-traumatic brain injury (TBI) subjects: a pilot study
Secondary ID [1] 1347 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 256679 0
Condition category
Condition code
Neurological 256836 256836 0 0
Other neurological disorders
Injuries and Accidents 256859 256859 0 0
Other injuries and accidents
Alternative and Complementary Medicine 256860 256860 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pine bark extract supplement, 2x500mg taken once per day for 6 weeks by oral capsule
Intervention code [1] 255910 0
Treatment: Other
Comparator / control treatment
Placebo control 2x500mg microcrystalline cellulose pill taken once per day for 6 weeks by oral capsule
Control group
Placebo

Outcomes
Primary outcome [1] 257703 0
Cognitive ability as meassured by the Computer Test of Information Processing
Timepoint [1] 257703 0
Baseline and 6, 12, 16 week follow up
Secondary outcome [1] 263047 0
Post Concussion Symptoms as neasured by the Post Concussion Symptoms Questionnaire
Timepoint [1] 263047 0
Baseline, 6, 12, 16 week follow up
Secondary outcome [2] 263048 0
Health Related Quality of Life as measured by the Health Relared Quality of Life Questionnaire - Short Form SF36
Timepoint [2] 263048 0
Baseline, 6, 12, 16 week follow up

Eligibility
Key inclusion criteria
6-12 months post mild TBI
Experiencing persistent cognitive difficulties
Willing to avoid taking other herbal supplements for the duration of the study
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Not fluent in English or have dysphasia
2) Unable to give informed consent
3) Known to have a medical condition that could impact on the results
4) Pregnancy or breastfeeding
5) Known allergy to pine trees
6) Current use of anticoagulant medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via concussion clinics in the Auckland Region of New Zealand (NZ) and through self-referral. After confirming eligibility to participate in the study, participants will be randomised to receive either the herbal supplement or the placebo treatment. Participants will be randomised centrally by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2442 0
New Zealand
State/province [1] 2442 0

Funding & Sponsors
Funding source category [1] 256407 0
Commercial sector/Industry
Name [1] 256407 0
Enzo Nutraceuticals Limited
Country [1] 256407 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology (AUT)
Address
AUT North Shore Campus
90 Akoranga Drive
Northcote, Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 251714 0
Commercial sector/Industry
Name [1] 251714 0
Enzo Nutraceuticals Limited
Address [1] 251714 0
Enzo Nutraceuticals Ltd,
10 Beatrice Tinsley Crescent,
North Harbour Industrial Estate,
Albany, North Shore, 0751
Country [1] 251714 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258464 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258464 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Road, Penrose
Auckland, 1061
Ethics committee country [1] 258464 0
New Zealand
Date submitted for ethics approval [1] 258464 0
Approval date [1] 258464 0
07/12/2009
Ethics approval number [1] 258464 0

Summary
Brief summary
Many people who have had a traumatic brain injury experience problems in processing information that can last for many years.Our pilot clincial trial will examine if a herbal supplement can improve memory and information processing if people who experienced a head injury 6-12 months ago and are experiencing persistent cognitive difficulties. The study hypothesis will that improvements in cognitive ability will occur in participants taking the herbal supplement in comparison to the group taking the placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30769 0
Address 30769 0
Country 30769 0
Phone 30769 0
Fax 30769 0
Email 30769 0
Contact person for public queries
Name 14016 0
Alice Theadom
Address 14016 0
AA254C, AUT North Shore Campus
90 Akoranga Drive
Northcote, Auckland, 1142
Country 14016 0
New Zealand
Phone 14016 0
0064 9 921 9999 x7805
Fax 14016 0
Email 14016 0
alice.theadom@aut.ac.nz
Contact person for scientific queries
Name 4944 0
Valery Feigin
Address 4944 0
AA254A, AUT North Shore Campus
90 Akoranga Drive
Northcote, Auckland, 1142
Country 4944 0
New Zealand
Phone 4944 0
0064 9 921 9166
Fax 4944 0
Email 4944 0
valery.feigin@aut.ac.nz

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
No additional documents have been identified.