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

NCT07246850 | Active Not Recruiting

• 1 other identifier: 20694
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sore-throat; Common Cold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Beekeeper's Propolis Throat Spray

EXPERIMENTAL

Dietary Supplement: Beekeeper's Propolis Throat Spray

Placebo Throat Spray

PLACEBO COMPARATOR

Dietary Supplement: Placebo Throat Spray

Interventions

Beekeeper's Propolis Throat Spray DIETARY_SUPPLEMENT

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.

Beekeeper's Propolis Throat Spray

Placebo Throat Spray DIETARY_SUPPLEMENT

Participants will administer four sprays of a placebo throat spray into the back of the mouth once daily in the morning for 16 weeks.

Placebo Throat Spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beekeeper's Naturals Inc: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

MeSH Terms

Conditions

Pharyngitis; Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 24, 2025
• Study Start: December 30, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)