NCT07642648Not yet recruitingPhase 2
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
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- RDC Clinical Pty Ltd
- Enrollment
- 300
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Investigators
Amanda Rao
PhD
RDC Clinical Pty Ltd
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