Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000417280
Ethics application status
Approved
Date submitted
8/05/2009
Date registered
5/06/2009
Date last updated
6/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of the immunomodulatory effects of Echinacea
Scientific title
investigations into the effects of supplementation with echinacea on parameters of the immune response in healthy adults
Secondary ID [1] 859 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune system response 4740 0
Condition category
Condition code
Alternative and Complementary Medicine 237071 237071 0 0
Herbal remedies
Inflammatory and Immune System 237072 237072 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The tablets contain 675mg herb equivalent of Echinacea purpurea and 600mg herb equivalent of Echinacea angustifolia. Participants will take 2 tablets twice a day for 2 weeks
Intervention code [1] 4512 0
Prevention
Comparator / control treatment
Each participant is their own control as they are tested before and after echinacea supplementation
Control group
Active

Outcomes
Primary outcome [1] 5908 0
Blood analysis of white blood cell types, heat chock protein expression levels and alkylamide concentrations will be assessed
Timepoint [1] 5908 0
Baseline and on completion of the 2 week supplementation period
Secondary outcome [1] 241961 0
Single dose pharmacokinetics will be examined in blood before and after the supplementation period.
Timepoint [1] 241961 0
Before and after the 2 weeks supplementation period

Eligibility
Key inclusion criteria
Healthy individuals exhibiting no sign of respiratory illness in the 2 weeks before the trial commences.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Plant/pollen allery
Lactation or pregnancy
Diagnosed respiratory disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4917 0
Commercial sector/Industry
Name [1] 4917 0
MediHerb Pty Ltd
Country [1] 4917 0
Australia
Funding source category [2] 4918 0
Government body
Name [2] 4918 0
AusIndustry - Commercial Ready Grant
Country [2] 4918 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MediHerb Pty Ltd
Address
3/85 Brandl St
Eight Mile Plains
QLD 4113
Country
Australia
Secondary sponsor category [1] 4447 0
None
Name [1] 4447 0
Address [1] 4447 0
Country [1] 4447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6983 0
Human Research Ethics Committee
Ethics committee address [1] 6983 0
University of New England
Research Development and Integrity Research Services
Armidale, NSW 2351
Ethics committee country [1] 6983 0
Australia
Date submitted for ethics approval [1] 6983 0
Approval date [1] 6983 0
06/03/2009
Ethics approval number [1] 6983 0
HE09/017

Summary
Brief summary
It is widely accepted that stimulation of the immune system is responsible for the perceived benefits of Echinacea. This study will examine the prophylactic use of echinacea on white cell counts, natural killer cell functionality, heat shock protein expression and echinacea pharmacokinetics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29585 0
Address 29585 0
Country 29585 0
Phone 29585 0
Fax 29585 0
Email 29585 0
Contact person for public queries
Name 12832 0
Dr Linda Agnew
Address 12832 0
Centre for Bioactive Discovery in Health and Ageing
School of Science and Technology
McClymont Building
University of New England
Armidale NSW 2351
Country 12832 0
Australia
Phone 12832 0
+61 2 6773 2631
Fax 12832 0
Email 12832 0
[email protected]
Contact person for scientific queries
Name 3760 0
Dr Linda Agnew
Address 3760 0
Centre for Bioactive Discovery in Health and Ageing
School of Science and Technology
McClymont Building
University of New England
Armidale NSW 2351
Country 3760 0
Australia
Phone 3760 0
+61 2 6773 2631
Fax 3760 0
Email 3760 0
[email protected]

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.