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.
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.
Prof Luis Vitetta
200 participants
Jun 25, 2015
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- Healthy volunteers with no cold or flu symptoms
- Capable of providing informed consent
- Able to attend the designated clinics
Exclusion Criteria12
- 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.
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Interventions
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.
Locations(1)
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ACTRN12615000506594