Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001301853
Ethics application status
Approved
Date submitted
14/12/2012
Date registered
17/12/2012
Date last updated
16/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of Elderberry capsules in the prevention of upper respiratory symptoms associated with long distance travel.
Scientific title
Randomised, double-blind, placebo-controlled trial of Elderberry supplementation preventing upper respiratory symptoms in air travellers.
Secondary ID [1] 281676 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper respiratory symptoms 287960 0
Condition category
Condition code
Respiratory 288346 288346 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 288347 288347 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Elderberry capsules (active) are 300mg of standardised Elderberry membrane filtered extract powder (22% polyphenols, 15% anthocyanins) and 150mg of rice flour. Participants will take 2 capsules per 24 hour period for 10 days prior to travel, 3 capsules per 24 hour during travel and a further 4 days at their destination. Trial participation lasts 16 days including the first 4 or 5 days on arriving at their destinations. Travel duration will differ between participants and should not exceed 72 hours of travel. Travel duration is defined as leaving home to arriving at the accommodation at the destination.
Intervention code [1] 286209 0
Prevention
Intervention code [2] 286228 0
Treatment: Other
Comparator / control treatment
Placebo capsules comprises of 350mg of rice flour and 100mg of iron (III) oxide (red) and are appearance matched to the active capsules but will not contain any active Elderberry ingredients. Dosing and duration will be the same as the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 288521 0
Active vs Placebo Group comparison for the number of participants suffering from upper respiratory symptoms - using Jackson Score.
Timepoint [1] 288521 0
Daily (16 days participation)
Primary outcome [2] 288523 0
Active vs Placebo group comparison in Quality of Life and upper respiratory symptoms using SF-12 cute and WURSS-21 surveys.
Timepoint [2] 288523 0
1) Baseline (Day 1)
2) 2 days prior to travel
3) End of trial participation (Day 16)
Secondary outcome [1] 300387 0
Level of Stress prior to the commencement of trial using Perceived Stress Scale (PSS) survey
Timepoint [1] 300387 0
Baseline

Eligibility
Key inclusion criteria
1) travelling a minimum of 7 hours flight 2) travelling via economy class 3) planning a minimum stay of 4 days at destination
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Diagnosed respiratory disease
2) Lactation or pregnancy
3) Pollen/plant allergy
4) Serious inflammatory or immunological conditions

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)
Concealed allocation is prepared by a statistician not involved in the study. A randomization schedule is prepared using a random number generated by computer prior to the enrolment of the first participant. Another person not involved in the study placed randomized numbers into opaque envelopes. The assignments were placed in sealed opaque numbered envelopes prior to the onset of the study and treatments determined after the baseline assessments had been completed. Each person who met the eligibility criteria was given the next opaque envelope treatment in sequential order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
25/02/2013
Actual
26/04/2013
Date of last participant enrolment
Anticipated
Actual
10/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,SA,TAS,WA

Funding & Sponsors
Funding source category [1] 286475 0
Commercial sector/Industry
Name [1] 286475 0
Iprona AG
Country [1] 286475 0
Italy
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 285264 0
None
Name [1] 285264 0
Address [1] 285264 0
Country [1] 285264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288553 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 288553 0
170 Kessels Road
Nathan
QLD 4111
Ethics committee country [1] 288553 0
Australia
Date submitted for ethics approval [1] 288553 0
Approval date [1] 288553 0
18/12/2012
Ethics approval number [1] 288553 0
PHM/08/12/HREC

Summary
Brief summary
This study will investigate the effectiveness of Elderberry lozenges in the prevention of upper respiratory symptoms associated with long distance travel.
Trial website
http://www.griffith.edu.au/health/school-pharmacy/research/elderberry-clinical-trial
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36614 0
Dr Evelin Tiralongo
Address 36614 0
School of Pharmacy
Griffith University
Gold Coast campus
QLD 4222
Country 36614 0
Australia
Phone 36614 0
+61 (0) 7 5552 7098
Fax 36614 0
Email 36614 0
[email protected]
Contact person for public queries
Name 36615 0
Dr Evelin Tiralongo
Address 36615 0
School of Pharmacy
Griffith University
Gold Coast campus
QLD 4222
Country 36615 0
Australia
Phone 36615 0
+61 (0) 7 5552 7098
Fax 36615 0
Email 36615 0
[email protected]
Contact person for scientific queries
Name 36616 0
Dr Evelin Tiralongo
Address 36616 0
School of Pharmacy
Griffith University
Gold Coast campus
QLD 4222
Country 36616 0
Australia
Phone 36616 0
+61 (0) 7 5552 7098
Fax 36616 0
Email 36616 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
SourceTitleYear of PublicationDOI
EmbaseElderberry supplementation reduces cold duration and symptoms in air-travellers: A randomized, double-blind placebo-controlled clinical trial.2016https://dx.doi.org/10.3390/nu8040182
N.B. These documents automatically identified may not have been verified by the study sponsor.