Determining the effectiveness of Sambucol in reducing the duration and symptoms of the common cold in children and teens
Pharmacare Pty Ltd
198 participants
Jun 19, 2023
Observational
Conditions
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.
Eligibility
Inclusion Criteria5
- Willingness to not take any other over-the-counter cold medication for the duration of the study
- Children that are generally healthy
- Commenced cold within in the last 3 days (72 hours)
- 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.
- Parent / legal guardian has provided informed consent.
Exclusion Criteria8
- 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
- History of severe allergic or idiosyncratic reaction reactions or anaphylaxis to any medication; and known allergy to elderberry or excipients of the investigational product
- Currently on regular treatment with antibiotics, corticosteroids, antihistamines, antivirals, non-steroidal anti-inflammatory drugs, anticancer drugs, or immune suppressants.
- Use of antibiotics within 4 weeks before commencement.
- Use of any other complementary medicine (herbal or vitamin or mineral supplements) during the trial.
- Influenza vaccination within 3 months before commencement.
- Living in a home exposed to passive smoking.
- Known asthma, chronic disease (e.g., diabetes, cystic fibrosis, arthritis, genetic condition or severe eczema) or immunodeficiency disorder (e.g., Childhood leukemia).
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Interventions
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.
Locations(1)
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ACTRN12623000299606