Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000299606
Ethics application status
Approved
Date submitted
20/09/2022
Date registered
17/03/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
17/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the effectiveness of Sambucol in reducing the duration and symptoms of the common cold in children and teens
Scientific title
Determining the effectiveness of Sambucol in reducing the duration and symptoms of the common cold in children and teens
Secondary ID [1] 307880 0
Protocol ID: CATS22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cold 327511 0
Flu-like symptoms 327512 0
Condition category
Condition code
Respiratory 324622 324622 0 0
Other respiratory disorders / diseases
Infection 325898 325898 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eligible participants, who are aged 2-17 years, have parental consent to take part, currently are experiencing cold and/or flu-like symptoms and consuming Sambucol for the treatment of these symptoms, will be asked to report their symptoms, severity and consumption of Sambucol until their symptoms resolve. Duration will vary but participation is expected to be between 2 and 15 days, until cold and flu-like symptoms have subsided, or 15 days has lapsed.
Information will be collected using a purpose-built study app “Sambucol Research”.
The app contains a daily (once a day at the same time of day) survey for participants to report:
- Personal details including name, age and address
- Symptoms of cold and flu
- Severity of their symptoms
- How often and how much Sambucol they consume
The Sambucol product isn’t being administered by researchers however, we will collect information about consumption during participation. As part of the daily surveys, participants will indicate frequency and amount of Sambucol consumed for a period of between 2-15 days (until cold and flu-like symptoms have subsided or 15 days has lapsed).
Parents of children who are aged 10 or under will provide this information via the study app. Those aged over 10 will provide the information on the study app themselves, under parental supervision.
Intervention code [1] 324343 0
Not applicable
Comparator / control treatment
There is no formal reference group as the study is open-label observational in nature. A comparison will be made to two existing data sets:
1. Data describing the incidence, severity and duration of different cold symptoms in children over a six-week period. (Troullos E, Baird L, Jayawardena S. Common Cold Symptoms in Children: Results of an Internet-Based Surveillance Program. J Med Internet Res. 2014 Jun 19;16(6):e144.) This study was not a randomised controlled trial or an intervention. The study observed duration and severity of colds and as such was not registered.

2. A randomised controlled trial of adults aged 18-70 with cold symptoms who took either Sambucol (Black Elderberry extract) or placebo (identical syrup to the active group, minus the Black Elderberry extract). (Rao A, Sethi M, Dick C. 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. Confidential Report to Pharmacare. Sydney: RDC Global; 2015.) Registration number: ACTRN 12615000506594
Control group
Historical

Outcomes
Primary outcome [1] 332440 0
Severity of cold symptoms
Cold and flu-like symptoms (E.g. Runny nose, cough, tiredness, feverishness, body aches or pains) will be monitored using a study symptom checklist created for this study comprising a total of 16 items, once daily for the duration of a participant’s enrolment in the study.
The checklist comprises elements that correspond with symptoms listed on the ‘Wisconsin Upper Respiratory Symptom Survey for Kids’, the ‘Wisconsin Upper Respiratory Symptom Survey’ the ‘Daily Cold Symptom Severity Score’ and the ‘Canadian Acute Respiratory Illness and Flu Scale’.

References
1. Schmit KM, Brown R, Hayer S, Checovich MM, Gern JE, Wald ER, et al. Wisconsin Upper Respiratory Symptom Survey for Kids: Validation of an Illness-specific Quality of Life Instrument. Pediatr Res. 2021 Dec;90(6):1207–14.
2. Barrett B, Brown R, Mundt M, Safdar N, Dye L, Maberry R, Alt J. The Wisconsin Upper Respiratory Symptom Survey is responsive, reliable, and valid. J Clin Epidemiol. 2005 Jun;58(6):609-17. doi: 10.1016/j.jclinepi.2004.11.019. PMID: 15878475; PMCID: PMC7119015.
3. Troullos E, Baird L, Jayawardena S. Common Cold Symptoms in Children: Results of an Internet-Based Surveillance Program. J Med Internet Res. 2014 Jun 19;16(6):e144.
4. Taylor JA, Weber WJ, Martin ET, McCarty RL, Englund JA. Development of a Symptom Score for Clinical Studies to Identify Children with a Documented Viral Upper Respiratory Tract Infection. Pediatr Res. 2010 Sep;68(3):252–7.



Timepoint [1] 332440 0
Daily, until cold resolves.
Secondary outcome [1] 413510 0
Duration of cold symptoms.
Duration of cold symptoms will be measured by the number of days a symptom is self-reported as being present, via the study app.
Timepoint [1] 413510 0
Daily, until cold resolves.

Eligibility
Key inclusion criteria
1. Willingness to not take any other over-the-counter cold medication for the duration of the study
2. Children that are generally healthy
3. Commenced cold within in the last 3 days (72 hours)
4. Have at least one of the following symptoms: stuffy or runny nose or discolored nasal secretions, sneezing; scratchy or sore throat; cough; or hoarseness of voice.
5. Parent / legal guardian has provided informed consent.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children and adolescents who meet the following exclusion criteria will not be included in the trial:
1. Significant acute illness (including a previous common cold) within the 2 weeks prior to commencement including allergic rhinitis; or an active systemic infection or medical condition that might require treatment or therapeutic intervention during the study
2. History of severe allergic or idiosyncratic reaction reactions or anaphylaxis to any medication; and known allergy to elderberry or excipients of the investigational product
3. Currently on regular treatment with antibiotics, corticosteroids, antihistamines, antivirals, non-steroidal anti-inflammatory drugs, anticancer drugs, or immune suppressants.
4. Use of antibiotics within 4 weeks before commencement.
5. Use of any other complementary medicine (herbal or vitamin or mineral supplements) during the trial.
6. Influenza vaccination within 3 months before commencement.
7. Living in a home exposed to passive smoking.
8. Known asthma, chronic disease (e.g., diabetes, cystic fibrosis, arthritis, genetic condition or severe eczema) or immunodeficiency disorder (e.g., Childhood leukemia).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
19/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
198
Accrual to date
61
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312154 0
Commercial sector/Industry
Name [1] 312154 0
Pharmacare Pty Ltd
Country [1] 312154 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pharmacare Pty Ltd
Address
18 Jubilee Avenue, Warriewood, NSW, 2102
Country
Australia
Secondary sponsor category [1] 313680 0
None
Name [1] 313680 0
Address [1] 313680 0
Country [1] 313680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311545 0
Bellberry Ltd
Ethics committee address [1] 311545 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 311545 0
Australia
Date submitted for ethics approval [1] 311545 0
13/09/2022
Approval date [1] 311545 0
23/03/2023
Ethics approval number [1] 311545 0
2022-09-1018

Summary
Brief summary
This is an observational tele trial to determine the effectiveness of Sambucol in the management of the symptoms of the common cold and flu-like illnesses in children and adolescents aged between 2 years and 17 years who are already committed to consuming Sambucol as part of their own routine self-care (with parental consent and monitoring). Sambucol Black Elderberry Cold & Flu is a liquid that has an extract of Elderberry that is safe for children and teens to consume to help relieve their cold and flu symptoms. This same Elderberry extract has been shown to be useful in helping to resolve cold and flu symptoms like coughing, sneezing and headaches in adults. This study is testing if the same extract in Sambucol Black Elderberry Cold & Flu is useful for children and adolescents with cold and flu symptoms or not. The study will be conducted online via a study app and will measure the duration and severity of cold symptoms of participants who are taking Sambucol Black Elderberry Cold & Flu, until the illness resolves.
The researchers expect that Sambucol will significantly reduce the severity of the symptoms of the common cold in comparison to existing data on children with cold and flu symptoms. It is also expected that Sambucol will reduce the severity of the symptoms of the common cold in children comparable to reductions observed in clinical trials with adults taking Sambucol, and significantly greater than adults taking placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121486 0
Prof Stephen Myers
Address 121486 0
NatMed Research
9 Bundjalung Rd., Evans Head NSW 2473
Country 121486 0
Australia
Phone 121486 0
+61 421612713
Fax 121486 0
Email 121486 0
stephen.myers@natmedresearch.com.au
Contact person for public queries
Name 121487 0
Prof Stephen Myers
Address 121487 0
NatMed Research
9 Bundjalung Rd., Evans Head NSW 2473
Country 121487 0
Australia
Phone 121487 0
+61 421612713
Fax 121487 0
Email 121487 0
stephen.myers@natmedresearch.com.au
Contact person for scientific queries
Name 121488 0
Prof Stephen Myers
Address 121488 0
NatMed Research
9 Bundjalung Rd., Evans Head NSW 2473
Country 121488 0
Australia
Phone 121488 0
+61 421612713
Fax 121488 0
Email 121488 0
stephen.myers@natmedresearch.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.