A Novel Cold and Flu Herbal Blend for Reducing the Duration and Severity of the Common Cold
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRDC Clinical Pty Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18-65 years living in Australia
Individuals with a history of recurrent Upper Respiratory Tract infections (URTI) (at least one episode per year)
Able to provide informed consent
Generally healthy
Disqualifiers
Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, autoimmune conditions, neurological disorders such as multiple sclerosis.
Unstable illness e.g., changing medication/treatment.
BMI <18.5, >30
Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
Trial design
Design model
Parallel
Treatments tested in this trial
Novel Herbal Cold & Flu Blend
Dietary supplementEach 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.
Placebo
Other interventionEach 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Novel Herbal Cold & Flu BlendExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 16Secondary outcomes
1
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 162
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 163
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 164
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 16Other outcomes
1
Safety: Occurrence of adverse events and Serious Adverse Events
Occurrence of adverse events and Serious Adverse Events
Time frame
Baseline to week 16Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
RDC Clinical Pty Ltd
Lead sponsor
iNova Pharmaceuticals
Collaborator
Source ClinicalTrials.gov
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