NCT07246850Active, not recruitingNot Applicable
A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Throat Spray on the Incidence and Duration of Sickness
Beekeeper's Naturals Inc1 site in 1 country100 target enrollmentStarted: December 30, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Beekeeper's Naturals Inc
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes in incidence and duration of sickness
Study Overview
Brief Summary
This is a randomized, triple-blind, placebo-controlled clinical trial evaluating the effects of Beekeeper's Naturals Propolis Immune Support Throat Spray on the incidence and duration of sickness over a 16-week period. The study will enroll 100 healthy adults aged 18 to 65.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be male or female
- •Be aged 18-65
- •Meet at least one of the following criteria:
- •Work in a hospital or other healthcare setting Work in a school
- •Have a child/children under the age of 10
- •Be willing to take the test or placebo product once daily and complete study questionnaires every four weeks for the 16-week study period
- •Be willing to refrain from taking any over-the-counter products, herbal remedies, or supplements that target immune function during the study period and for two weeks prior.
- •Be willing to maintain their current diet, sleep schedule, and activity level for the duration of the study.
- •Be in good general health and not live with any uncontrolled chronic conditions.
- •Reside in the United States.
Exclusion Criteria
- •Has undergone any surgeries or invasive treatments in the past six months or plans to undergo any during the study period
- •Anyone with seasonal allergies
- •Anyone who follows a restrictive diet (e.g., keto, vegan, raw, carnivore, etc.).
- •Anyone who got a vaccination in the last 2 weeks.
- •Anyone taking one or more prescription medications:
- •Corticosteroids: Prednisone (prednisone), Deltasone (prednisolone), Medrol (methylprednisolone), Decadron (dexamethasone), Cortef (hydrocortisone), Kenalog (triamcinolone), Flonase (fluticasone), Nasonex (mometasone) Biologics (Immunomodulating Agents): Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), Stelara (ustekinumab), Cosentyx (secukinumab), Taltz (ixekizumab), Orencia (abatacept), Simponi (golimumab), Xeljanz (tofacitinib), Rituxan (rituximab), Actemra (tocilizumab), Kineret (anakinra) DMARDs (Disease-Modifying Antirheumatic Drugs): Methotrexate (methotrexate), Plaquenil (hydroxychloroquine), Arava (leflunomide), Azulfidine (sulfasalazine), Imuran (azathioprine), CellCept (mycophenolate mofetil), Cytoxan (cyclophosphamide) JAK Inhibitors: Olumiant (baricitinib), Rinvoq (upadacitinib), Jakafi (ruxolitinib) Other Immunosuppressive Medications: Prograf (tacrolimus), Neoral, Sandimmune (cyclosporine), Rapamune (sirolimus), Zortress (everolimus)
- •Has had any major illness in the past three months.
- •Drinks heavily (defined as 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- •Uses illicit drugs.
- •Has known allergies or hypersensitivities to any of the study product ingredients.
- •Is immunocompromised due to a medical condition or due to immunosuppressive medications or treatments.
- •Has any known autoimmune conditions.
- •Has any chronic health conditions that could impact participation in the study, including cancer, liver, or mental health disorders.
- •Has known serious allergic reactions requiring the use of an Epi-Pen.
- •Is currently pregnant, trying to conceive, or breastfeeding.
- •Is currently participating in another research study or plans to do so during the 16-week study period.
- •Has a history of substance abuse.
- •Is currently a smoker or has been a smoker in the past three months.
Arms & Interventions
Beekeeper's Propolis Throat Spray
Experimental
Intervention: Beekeeper's Propolis Throat Spray (Dietary Supplement)
Placebo Throat Spray
Placebo Comparator
Intervention: Placebo Throat Spray (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in incidence and duration of sickness
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Self-reported via questionnaires comparing frequency and duration of illness episodes between groups
Secondary Outcomes
- Perceived improvement in overall health(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Perceived improvement in overall well-being(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Perceived immune system support(Baseline, Week 4, Week 8, Week 12, and Week 16)
Investigators
Study Sites (1)
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