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

Status

Active, not recruiting

Conditions

Sore-throat

Common Cold

Treatments

Dietary Supplement: Placebo Throat Spray

Dietary Supplement: Beekeeper's Propolis Throat Spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT07246850

20694 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.