Common Cold, Sore-throat
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBeekeeper's Propolis Throat Spray
Participants will administer four sprays of Beekeeper's Propolis Throat Spray into the back of the mouth once daily in the morning for 16 weeks.
DIETARY_SUPPLEMENTPlacebo Throat Spray
Participants will administer four sprays of a placebo throat spray into the back of the mouth once daily in the morning for 16 weeks.
Sponsors
Citruslabs
Beekeeper's Naturals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in incidence and duration of sickness | Baseline, Weeks 4, 8, 12, and 16 | Self-reported via questionnaires comparing frequency and duration of illness episodes between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived improvement in overall health | Baseline, Week 4, Week 8, Week 12, and Week 16 | Participants will report perceived changes in their overall health using self-administered questionnaires. |
| Perceived improvement in overall well-being | Baseline, Week 4, Week 8, Week 12, and Week 16 | Participants will report their sense of overall well-being using self-administered questionnaires throughout the study. |
| Perceived immune system support | Baseline, Week 4, Week 8, Week 12, and Week 16 | Participants will rate their perception of immune system support using self-administered questionnaires during the study. |
Countries
United States
Outcome results
None listed