Common Cold, URTI
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNovel Herbal Cold & Flu Blend
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.
OTHERPlacebo
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.
Sponsors
RDC Clinical Pty Ltd
iNova Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTAmanda Rao
STUDY_DIRECTOREmily MacNaughton
iNova Pharmaceuticals
Outcome results
None listed