A Novel Cold and Flu Herbal Blend for Reducing the Duration and Severity of the Common Cold

• Novel Herbal Cold & Flu Blend (Dietary supplement): 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.
• Placebo (Other): 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.

Primary outcomes

• Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system [Baseline to week 16]: Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system

Secondary outcomes

• Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system. [Baseline to week 16]: 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.
• Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system.. [Baseline to week 16]: 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..
• Number of days of absence from work / school. [Baseline to week 16]: Change from baseline to the end of the Common Cold episode in Number of days of absence from work / school.
• Perception of efficacy rated on the Treatment Satisfaction VAS. [Baseline to week 16]: Change from baseline to the end of the Common Cold episode in Perception of efficacy rated on the Treatment Satisfaction VAS.
• Safety via Adverse Event reporting and incident rate ratio between active and placebo groups [Baseline to week 16]: 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
• Use of rescue medication for an URTI [Baseline to week 16]: Change from baseline to the end of the Common Cold episode in Use of rescue medication for an URTI e.g. Paracetamol, Ibuprofen.

Other outcomes

• Safety: Occurrence of adverse events and Serious Adverse Events [Baseline to week 16]: Occurrence of adverse events and Serious Adverse Events

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* 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
* Agree to not participate in another clinical trial while enrolled in this trial
* Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period
* Females of childbearing potential must use a prescribed form of birth control (e.g. oral contraceptive)

Exclusion Criteria:

* 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.
* Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
* Active smokers, nicotine use (including vaping/e-cigarettes) or drug (prescription or illegal substances) abuse
* Current alcohol use (>21 alcoholic drinks week)
* Allergic to any of the ingredients in the active or placebo formula
* Allergic to plants in the Asteraceae family
* Pregnant or lactating woman
* Regular use of medications that would affect the immune and/or the inflammatory response e.g. antihistamines, anti-inflammatories, immunosuppressants, steroids excluding topical steroid use.
* Use of anticoagulant medications such as warfarin.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Participants with allergic rhinitis
* Regular use of antihistamines
* Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.

• Emily MacNaughton, Study director, iNova Pharmaceuticals