Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000328279
Ethics application status
Approved
Date submitted
9/03/2009
Date registered
22/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The prevention of colds and flus with Echinacea for long economy flights
Scientific title
Investigations into the effectiveness of a standardised Echinacea preparation in preventing colds, flus and other respiratory disorders for air-travellers on long economy flights
Secondary ID [1] 252158 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
airline travel related colds, flus and other respiratory disorders 4438 0
Condition category
Condition code
Alternative and Complementary Medicine 4706 4706 0 0
Herbal remedies
Respiratory 237069 237069 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 237070 237070 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention tablets contain 675mg herb equivalent of Echinacea purpurea and 600mg herb equivalent of Echinacea angustifolia. Participants will take 1 tablet twice a day for 2 weeks prior to travel, 2 tablets twice a day when flying, 1 tablet twice a day during their time away. If the participant experiences symptons of a cold or flu, they will take 3 tablets twice a day for a maximum of 4 days before returning to the normal 1 tablet twice a day dose.
Intervention code [1] 4184 0
Prevention
Comparator / control treatment
Placebo tablets are appearance matched using maltodextrin, povidone and permicol brown colour to simulate the missing echinacea. All other excipients are the same. Dosing and duration will be the same as for the intervention treatment arm.
Control group
Placebo

Outcomes
Primary outcome [1] 5574 0
A decrease in travel related colds, flus and other respiratory disorders.
Timepoint [1] 5574 0
Participants will keep a daily diary on their health status from 2 weeks prior to departure, during their travels and for 2 weeks after they return home.
Secondary outcome [1] 9386 0
nil
Timepoint [1] 9386 0
nil

Eligibility
Key inclusion criteria
travel via economy class from Australia to Europe or North America

travel period is between 2 and 4 weeks

Participants must be in good health with no colds in the 2 weeks before they start the trial
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pollen/plant allergy
lactation or pregnancy
diagnosed respiratory disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
blinding and randomisation has already occurred. Patients will just be allocated the next patient number and the tablets associated with that number. Patient numbers and tablets were allocated off-site by the sponsor
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
use of a website that randomises treatments when given the number of partients and the protocol.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4631 0
Commercial sector/Industry
Name [1] 4631 0
MediHerb Pty Ltd
Country [1] 4631 0
Australia
Funding source category [2] 4916 0
Government body
Name [2] 4916 0
AusIndustry Commercial Ready Grant
Country [2] 4916 0
Australia
Funding source category [3] 257249 0
Commercial sector/Industry
Name [3] 257249 0
MediHerb Pty Ltd
Country [3] 257249 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MediHerb Pty Ltd
Address
3/85 Brandl St
Eight Mile Plains
Queensland 4113
Country
Australia
Secondary sponsor category [1] 4175 0
None
Name [1] 4175 0
Address [1] 4175 0
Country [1] 4175 0
Secondary sponsor category [2] 256492 0
None
Name [2] 256492 0
New secondary sponsor name. Please modify.
Address [2] 256492 0
New secondary sponsor address. Please modify.
Country [2] 256492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6982 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 6982 0
Office for Research, Bray Centre (N54), Nathan Campus, Griffith University
170 Kessels Road, Nathan, Queensland 4111
Ethics committee country [1] 6982 0
Australia
Date submitted for ethics approval [1] 6982 0
Approval date [1] 6982 0
17/12/2008
Ethics approval number [1] 6982 0
PHM/06/08HREC

Summary
Brief summary
Echinacea has shown immuno-modulating effects and this study will investigate the efficacy of an echinacea preparation in the prevention of respiratory and other symptoms associated with air travel.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29366 0
Address 29366 0
Country 29366 0
Phone 29366 0
Fax 29366 0
Email 29366 0
Contact person for public queries
Name 12613 0
Shirley Wee
Address 12613 0
Genomics Research Centre Clinic
Griffith University
Southport
Queensland 4222
Country 12613 0
Australia
Phone 12613 0
+61 7 5552 9773
Fax 12613 0
Email 12613 0
[email protected]
Contact person for scientific queries
Name 3541 0
Dr Evelin Tiralongo
Address 3541 0
School of Pharmacy
Griffith University
Gold Coast Campus
Queensland 4222
Country 3541 0
Australia
Phone 3541 0
+61 7 5552 7098
Fax 3541 0
Email 3541 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.