Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001199808
Ethics application status
Approved
Date submitted
14/10/2012
Date registered
14/11/2012
Date last updated
12/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to evaluate the safety and efficacy of a complementary medicine formulation, to help relieve cold & flu symptoms and reduce duration of a cold, in otherwise healthy adults.
Scientific title
A prospective double blind, randomised, placebo-controlled study to evaluate the safety and efficacy of a complementary medicine formulation, to help relieve cold & flu symptoms and reduce duration of a cold, in otherwise healthy adults.
Secondary ID [1] 281118 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of the Common Cold 287282 0
Treatment of Influenza 287283 0
Condition category
Condition code
Alternative and Complementary Medicine 287607 287607 0 0
Herbal remedies
Infection 287821 287821 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment commences on the day that the cold/flu symptoms appear and continue for the following 10 days. The trial is completed once a subject has experienced a cold/flu episode.

The Day-time capsule (1 capsule 4 times/day)

Echinacea purpurea juice equiv fresh flowering herb 4g,
Salix alba equiv. fresh stem bark 1.2g,
Ascorbic acid (Vitamin C) 250mg,
Zinc (as sulfate monohydrate), 12mg,
Garlic oil (Allium sativum) equiv. fresh bulb 2.5g,
Zingiber officinale equiv. dry rhizome 500mg and
Glycyrrhiza glabra equiv. dry rhizome 500mg

The Night-time Capsule (1 capsule each day before sleep):

Valeriana officinalis equiv. dry root 2g,
Echinacea purpurea juice equiv fresh flowering herb 2g,
Salix alba equiv. fresh stem bark 1g,
Garlic oil (Allium sativum ) 500mg and
Glycyrrhiza glabara equiv. dry rhizome 500mg.
Intervention code [1] 285575 0
Treatment: Other
Comparator / control treatment
Day-time capsules (1 capsule 4 times/day):

soya oil 1351mg

Night-time capsules (1 capsule each day before sleep):

soya oil 1249mg
Control group
Placebo

Outcomes
Primary outcome [1] 288043 0
Relief of cold and influenza symptoms
Timepoint [1] 288043 0
Severity of symptoms to be recorded from the time the cold/flu in contracted until the episode is fully resolved, using a daily diary containing the Wisconsin Upper Respiratory Symptom Survey Daily Symptom Report
Secondary outcome [1] 299330 0
nil
Timepoint [1] 299330 0
nil

Eligibility
Key inclusion criteria
Healthy volunteers aged between 18 and 65.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not using any form of vitamin or herbal product during the trial duration.

(Females) Be pregnant or attempting to conceive.

(Females) Be breastfeeding or be lactating for at least 3 months prior to study.

Participants that have active opportunistic infections or opportunistic malignancies requiring acute treatment.

Concurrent use of any other investigational product(s).

Presence of any other acute, recurrent or chronic ear, nose, throat and respiratory tract disease than the common cold (eg bronchitis, tonsillitis, allergic rhinitis, otitis, asthma etc)

Unintended weight loss of more than 15% of body weight in last six months.

Active substance abuse (alcohol or drug dependency).

Known or suspected hypersensitivity to ingredients of the trial intervention (i.e. Soy)

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)
The potential participants are screened by the medicial monitor for inclusion in the study. The eligible participants are enrolled by Investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the NUMBER. The investigator is blinded to the product randomized with the numbered containers labelled prior to delivery to Investigational Site. Product allocated as participants are enrolled in sequential order (1-44).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomized Clinical Trial (RCT)
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/10/2012
Actual
21/10/2012
Date of last participant enrolment
Anticipated
Actual
12/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286273 0
Commercial sector/Industry
Name [1] 286273 0
PharmaCare Laboratories Pty. Ltd.
Country [1] 286273 0
Australia
Primary sponsor type
Individual
Name
A/Professor Luis Vitetta
Address
Director
Centre for Integrative Clinical and Molecular Medicine
The University of Queensland, School of Medicine
Princess Alexandra Hospital, Woollongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 284954 0
Individual
Name [1] 284954 0
Amanda Rao
Address [1] 284954 0
RDC GLOBAL
PO Box 667
New Farm, Qld 4005
Australia
Country [1] 284954 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288201 0
Queensland University Institutional Ethics Committee
Ethics committee address [1] 288201 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072 Australia
Ethics committee country [1] 288201 0
Australia
Date submitted for ethics approval [1] 288201 0
Approval date [1] 288201 0
09/10/2012
Ethics approval number [1] 288201 0
2012000781

Summary
Brief summary
1. This is a double-blind, randomised, placebo-controlled study to evaluate the efficacy of a vitamin, mineral and herbal formulation. The aim is to investigate if the formulation reduces cold & flu symptoms including symptom duration compared to placebo.
2. All participants are provided with the cold/flu treatment pack – which includes the product (active treatment or placebo), a daily symptom diary and a pre-prepared QML pathology form for Influenza antigen testing.
3. If a participant experiences 2 or 3 more cold/flu symptoms during the 6 month study period (according to the Wisconsin Upper Respiratory Symptom Survey), they need to a) start treatment, b) have the antigen test taken at a local QML pathology collection centre, c) record their symptom severity in the diary every day until symptoms resolved.

4. Within 2 weeks from the cold/flu resolving, the participant is asked to attend a final interview, returning the diary and unused product.

5. There will be regular communication with all participants during the study. Once the number of cold/flu episodes reaches the quota (49 per group), all participants will be informed that the study has been completed. Therefore, it is expected that not all participants will experience a cold/flu episode while enrolled in the study.
Trial website
Recruitment: http://www.trialfacts.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34637 0
Miss Amanda Rao
Address 34637 0
RDC GLOBAL
PO Box 667
New Farm, Qld 4005
Australia
Country 34637 0
Australia
Phone 34637 0
+61 414 488 559
Fax 34637 0
Email 34637 0
[email protected]
Contact person for public queries
Name 17884 0
Miss Amanda Rao
Address 17884 0
362 Water Street Fortitude Valley Brisbane QLD 4005

Postal Address: P.O. Box 68 New Farm Brisbane QLD 4005
Country 17884 0
Australia
Phone 17884 0
+61 414 488 559
Fax 17884 0
Email 17884 0
[email protected]
Contact person for scientific queries
Name 8812 0
Miss Amanda Rao
Address 8812 0
362 Water Street Fortitude Valley Brisbane QLD 4005

Postal Address: P.O. Box 68 New Farm Brisbane QLD 4005
Country 8812 0
Australia
Phone 8812 0
+61 414 488 559
Fax 8812 0
Email 8812 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.