URTIPhase 2NOURTINCT07642648
A Novel Cold and Flu Herbal Blend for Reducing the Duration and Severity of the Common Cold
A Phase 2 study testing Novel Herbal Cold & Flu Blend in people with URTI and Common Cold, run by RDC Clinical Pty Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- URTI, Common Cold
- What is being tested?
- Novel Herbal Cold & Flu Blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Blinded Controlled Trial Evaluating the Efficacy of a Novel Herbal Cold and Flu Blend in Reducing the Duration and Severity of Symptoms of the Common Cold
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.
- Conditions
- URTI, Common Cold
- Being tested
- Novel Herbal Cold & Flu Blend, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Herbal Cold & Flu BlendDietary 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Novel Herbal Cold & Flu Blend |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to week 16
Secondary outcomes (6)
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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for URTIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iNova Pharmaceuticals
- Responsible party
- Principal investigator, Amanda Rao, RDC Clinical Pty Ltd
- Investigators
- Emily MacNaughton, Study director, iNova Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642648
- Sponsor's protocol ID
- NOURTI
- Acronym
- NOURTI
- Status last verified
- May 2026
- First submitted
- 7 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Controlled Trial Evaluating the Efficacy of a Novel Herbal Cold and Flu Blend in Reducing the Duration and Severity of Symptoms of the Common Cold
- ClinicalTrials.gov ID
- NCT07642648
- Acronym / sponsor ID
- NOURTI / NOURTI
- Conditions
- URTI, Common Cold
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- iNova Pharmaceuticals
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Herbal Cold & Flu Blend | Experimental | Dietary Supplement: Novel Herbal Cold & Flu BlendEach 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 | Placebo comparator | Other: PlaceboEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Herbal Cold & Flu BlendEach 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. | Dietary supplement | Novel Herbal Cold & Flu Blend |
| PlaceboEach 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. | Other | Placebo |
Primary outcome
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
Time frame: Baseline to week 16
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system
6 secondary outcomes
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..
Time frame: Baseline to week 16
Number of days of absence from work / school.
Time frame: Baseline to week 16
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
Time frame: Baseline to week 16
Use of rescue medication for an URTI
Time frame: Baseline to week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily MacNaughton study director
iNova Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Novel Herbal Cold & Flu Blend in people with URTI and Common Cold, run by RDC Clinical Pty Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Rao (+61(0)731024486, research@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of days that participant recorded symptom positive on the WURSS-24 scoring system (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.