The aim of this study is to evaluate the efficacy of a Novel Herbal Cold \& Flu Blend in reducing the duration of symptoms of the common cold. The secondary objective is to assess whether the investigational product reduces the severity of symptoms. Participants will be enrolled for 16 weeks, during this period they will take the assigned study product when they experience URTI symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Each 485mg capsule contains the Novel Herbal Cold \& Flu Blend. Participants will start taking the study product if they experience 2 or more URTI symptoms (as per the WURSS-24) or a fever above 38.0°C. Participants are to consume 2 capsules three times each day until symptoms resolve.
Each placebo capsule contains Microcrystalline cellulose, Colloidal Silicon dioxide, Magnesium Stearate and Sodium Metabisulfite. Participants will start taking the study product if they experience 2 or more URTI symptoms (as per the WURSS-24) or a fever above 38.0°C. Participants are to consume 2 capsules three times each day until symptoms resolve.
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
Time frame: Baseline to week 16
Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system.
Change from baseline to the end of the Common Cold episode in Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system.
Time frame: Baseline to week 16
Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system..
Change from baseline to the end of the Common Cold episode in Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system..
Time frame: Baseline to week 16
Number of days of absence from work / school.
Change from baseline to the end of the Common Cold episode in Number of days of absence from work / school.
Time frame: Baseline to week 16
Perception of efficacy rated on the Treatment Satisfaction VAS.
Change from baseline to the end of the Common Cold episode in Perception of efficacy rated on the Treatment Satisfaction VAS.
Time frame: Baseline to week 16
Safety via Adverse Event reporting and incident rate ratio between active and placebo groups
Change from baseline to the end of the Common Cold episode in Safety via Adverse Event reporting and incident rate ratio between active and placebo groups
Time frame: Baseline to week 16
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Use of rescue medication for an URTI
Change from baseline to the end of the Common Cold episode in Use of rescue medication for an URTI e.g. Paracetamol, Ibuprofen.
Time frame: Baseline to week 16