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NCT Number: NCT07642648

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

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Key information

Conditions

URTI Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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

Secondary outcomes

  1. Symptom severity based on the total sum of all parameters in the WURSS-24 scoring system.

    Time frame: 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.

  2. Cumulative scores of each individual parameter in the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) scoring system..

    Time frame: 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..

  3. Number of days of absence from work / school.

    Time frame: Baseline to week 16

    Change from baseline to the end of the Common Cold episode in Number of days of absence from work / school.

  4. Perception of efficacy rated on the Treatment Satisfaction VAS.

    Time frame: 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.

  5. Safety via Adverse Event reporting and incident rate ratio between active and placebo groups

    Time frame: 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

  6. Use of rescue medication for an URTI

    Time frame: 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

  1. Safety: Occurrence of adverse events and Serious Adverse Events

    Time frame: Baseline to week 16

    Occurrence of adverse events and Serious Adverse Events

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Rao

CONTACT

[email protected]

+61(0)731024486

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • iNova Pharmaceuticals

Registry information

Official study 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

Acronym: NOURTI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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