Active, not recruiting
Not applicable
A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Throat Spray on the Incidence and Duration of Sickness
Condition(s) studied
Sore-throatCommon Cold
Investigational drug(s) / intervention(s)
Beekeeper's Propolis Throat SprayPlacebo Throat Spray
Beekeeper'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.
Placebo 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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
| Citruslabs |
Las Vegas |
Nevada |
|