Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000506594
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
20/05/2015
Date last updated
8/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, randomised, placebo-controlled study to evaluate the safety and efficacy of Sambucol liquid formulation to reduce the duration and severity of the common cold and flu symptoms in adults.
Scientific title
A prospective, double-blind, randomised, placebo-controlled study to evaluate the safety and efficacy of a complementary medicine formulation, to help reduce duration and severity of cold and flu symptoms, in otherwise health adults.
Secondary ID [1] 286646 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of common cold 294975 0
Treatment of Influenza 295049 0
Condition category
Condition code
Alternative and Complementary Medicine 295237 295237 0 0
Herbal remedies
Infection 295238 295238 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment is an orally dosed liquid-form supplement containing a standardised elderberry extract (Sambucol). The dose is 15mL, taken 4 times daily, commenced within the first 24 hours of onset of symptoms of cold/flu and continued until complete resolution of symptoms. Once a person has experienced a cold/flu episode their participation in the trial is completed.

Active ingredient: Sambucus nigra (Black Elderberry) extract equivalent to fruit juice 5.7g/15ml liquid.

All participants are provided with the cold/flu treatment pack which includes the product (active treatment or placebo), a daily symptom diary, a thermometer and a pre-prepared QML pathology form for Influenza antigen testing.

If a participant experiences 3 or more cold/flu symptoms during the study period (according to the Wisconsin Upper Respiratory Symptom Survey), they need to a) start treatment, b) record their symptom severity and duration in the diary every day until symptoms resolved c) take temperature daily d) if temperature >38 degrees C have the antigen test taken at a
local QML pathology collection centre.

During the treatment period, a clinical trial nurse/investigator will make contact with each participant, at least every 2 days to ensure symptoms are not such that they require medical intervention/hospitalisation. If fever persists for greater than 3 days or if other symptoms worsen over a 5 day period then the participant will be referred to the referring medical consultant.

Within 2 weeks from the cold/flu resolving, the participant is asked to attend a final interview, returning the diary and unused product which will be used to monitor adherence.

Once the number of cold/flu episodes reaches the quota (120 cold and 80 flu episodes), 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.
Intervention code [1] 291789 0
Treatment: Other
Intervention code [2] 291842 0
Treatment: Drugs
Comparator / control treatment
15ml, 4 times daily of excipient ingredients only: glucose syrup, citric acid monohydrate, potassium sorbate, natural blackcurrent flavour, natural cranberry and water
Control group
Placebo

Outcomes
Primary outcome [1] 294990 0
Reduction of severity and duration of cold symptoms
Timepoint [1] 294990 0
Severity and duration of symptoms to be recorded from the time the cold is contracted until the episode is fully resolved, using a daily diary containing the Wisconsin Upper Respiratory Symptom Survey Daily Symptom Report
Primary outcome [2] 295066 0
Reducton in severity and duration of flu symptoms
Timepoint [2] 295066 0
Severity and duration of symptoms to be recorded from the time the flu is contracted until the episode is fully resolved, using a daily diary containing the Wisconsin Upper Respiratory Symptom Survey Daily Symptom Report
Secondary outcome [1] 314517 0
Nil
Timepoint [1] 314517 0
Nil

Eligibility
Key inclusion criteria
Healthy volunteers with no cold or flu symptoms
Capable of providing informed consent
Able to attend the designated clinics
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If they are using any other form of vitamin or herbal product for symptom relief during the episode;
If they are pregnant, breastfeeding (females) or attempting to conceive;
If they have active opportunistic infections or opportunistic malignancies requiring acute treatment;
If they are using any pharmaceutical product(s) for symptom relief during the episode;
If they are on immuno-suppressive medication such as corticosteroids or any other immune-modulating therapies;
If they have had a cold and flu vaccination in the last 6 months;
If they have uncontrolled diabetes, uncontrolled hypertension, liver or renal disease;
If the have a BMI >35;
If they have any other acute, recurrent or chronic ear, nose, throat and respiratory tract disease other than the common cold (eg bronchitis, tonsillitis, allergic rhinitis, otitis, bronchitis, asthma etc);
If they have experienced unintended weight loss of more than 15% of body weight in last six months;
If they are active substance abusers (alcohol or drug dependency); or
If they have known or suspected hypersensitivity to ingredients of the trial intervention.

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 investigator 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 (1-800).
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
Randomised Clinical Trial (RCT)
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2015
Actual
25/06/2015
Date of last participant enrolment
Anticipated
Actual
5/12/2016
Date of last data collection
Anticipated
1/06/2017
Actual
12/12/2016
Sample size
Target
200
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 291219 0
Commercial sector/Industry
Name [1] 291219 0
PharmaCare Laboratories Pty. Ltd.
Country [1] 291219 0
Australia
Primary sponsor type
Individual
Name
Prof Luis Vitetta
Address
Sydney Medical School
Edward Ford Building A27
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 289899 0
Individual
Name [1] 289899 0
Amanda Rao
Address [1] 289899 0
Integrated Health Global Pty Ltd
PO Box 667
NEW FARM QLD 4005
Country [1] 289899 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292782 0
Queensland Clinical Trials Network Inc.
Ethics committee address [1] 292782 0
Level 3
88 Jephson Street
TOOWONG QLD 4066
Ethics committee country [1] 292782 0
Australia
Date submitted for ethics approval [1] 292782 0
02/03/2015
Approval date [1] 292782 0
05/06/2015
Ethics approval number [1] 292782 0
HREC2015001

Summary
Brief summary
This is a double-blind, randomised, placebo-controlled study to evaluate the efficacy of a herbal formulation. The aim is to
investigate if the formulation reduces the severity and duration of cold & flu symptoms compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57006 0
Prof Luis Vitetta
Address 57006 0
Sydney Medical School
Edward Ford Building A27
The University of Sydney
NSW 2006
Country 57006 0
Australia
Phone 57006 0
+61 402 263 316
Fax 57006 0
Email 57006 0
luis_vitetta@medlab.co
Contact person for public queries
Name 57007 0
Ms Amanda Rao
Address 57007 0
Integrated Health Global Pty Ltd
PO Box 667
New Farm Brisbane
QLD 4005
Country 57007 0
Australia
Phone 57007 0
+61 414 488 559
Fax 57007 0
Email 57007 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 57008 0
Ms Amanda Rao
Address 57008 0
Integrated Health Global Pty Ltd
PO Box 667
New Farm Brisbane
QLD 4005
Country 57008 0
Australia
Phone 57008 0
+61 414 488 559
Fax 57008 0
Email 57008 0
amanda@rdcglobal.com.au

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

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