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.
- Conditions
- Treatment of common coldTreatment of InfluenzaAlternative and Complementary Medicine - Herbal remediesInfection - Other infectious diseases
- Registration Number
- ACTRN12615000506594
- Lead Sponsor
- Prof Luis Vitetta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Healthy volunteers with no cold or flu symptoms
Capable of providing informed consent
Able to attend the designated clinics
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of severity and duration of cold symptoms[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];Reducton in severity and duration of flu symptoms[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 Measures
Name Time Method il[Nil]