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

NCT07642648 | Not Yet Recruiting Phase 2

• 1 other identifier: NOURTI
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

URTI; Common Cold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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..

  Baseline to week 16

• Number of days of absence from work / school.

  Baseline to week 16

• 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

  Baseline to week 16

Other Outcomes (1)

• Safety: Occurrence of adverse events and Serious Adverse Events

  Baseline to week 16

Study Arms (2)

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.

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.

Other: Placebo

Interventions

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.

Novel Herbal Cold & Flu Blend

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• iNova Pharmaceuticals: collaborator

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Emily MacNaughton

  iNova Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Amanda Rao

CONTACT

+61(0)731024486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-05