A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Throat Spray on the Incidence and Duration of Sickness

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 Overview

• Status: Active, not recruiting
• Conditions: Common Cold; Sore-throat
• Intervention / Treatment: Dietary supplement: Beekeeper's Propolis Throat Spray; Dietary supplement: Placebo Throat Spray

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beekeeper's Propolis Throat Spray	Dietary supplement: 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 Comparator: Placebo Throat Spray	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in incidence and duration of sickness	Self-reported via questionnaires comparing frequency and duration of illness episodes between groups	Baseline, Weeks 4, 8, 12, and 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived improvement in overall health	Participants will report perceived changes in their overall health using self-administered questionnaires.	Baseline, Week 4, Week 8, Week 12, and Week 16
Perceived improvement in overall well-being	Participants will report their sense of overall well-being using self-administered questionnaires throughout the study.	Baseline, Week 4, Week 8, Week 12, and Week 16
Perceived immune system support	Participants will rate their perception of immune system support using self-administered questionnaires during the study.	Baseline, Week 4, Week 8, Week 12, and Week 16

Collaborators and Investigators

• Sponsor: Beekeeper's Naturals Inc
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Common Cold; Pharyngitis
• Other Study ID Numbers: 20694 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No