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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Common Cold; URTI
• Intervention / Treatment: Dietary supplement: Novel Herbal Cold & Flu Blend; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amanda Rao; Phone Number: +61(0)731024486; Email: research@rdcglobal.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel 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.	Dietary supplement: Novel 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.
Placebo Comparator: Placebo; 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.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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..	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: iNova Pharmaceuticals
• Investigators: Study Director: Emily MacNaughton, iNova Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 7, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: NOURTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No