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NCT07642648

PHASE2

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

Sponsor: RDC Clinical Pty Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-07

Completion Date

2027-12

Last Updated

2026-06-11

Healthy Volunteers

Yes

Conditions

URTI Common Cold

Interventions

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.

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.

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.