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| Name | Class |
|---|---|
| iNova Pharmaceuticals | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Herbal Cold & Flu Blend | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 16 |
| Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system.. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Occurrence of adverse events and Serious Adverse Events | Occurrence of adverse events and Serious Adverse Events | Baseline to week 16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Rao | Contact | +61(0)731024486 | research@rdcglobal.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Emily MacNaughton | iNova Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| 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. |
|
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.. |
| 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. | 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. | 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 | Baseline to week 16 |
| 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. | Baseline to week 16 |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |