Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 8:22 PM
Study NCT ID:
NCT07246850
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Throat Spray on the Incidence and Duration of Sickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in incidence and duration of sickness', 'timeFrame': 'Baseline, Weeks 4, 8, 12, and 16', 'description': 'Self-reported via questionnaires comparing frequency and duration of illness episodes between groups'}], 'secondaryOutcomes': [{'measure': 'Perceived improvement in overall health', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, and Week 16', 'description': 'Participants will report perceived changes in their overall health using self-administered questionnaires.'}, {'measure': 'Perceived improvement in overall well-being', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, and Week 16', 'description': 'Participants will report their sense of overall well-being using self-administered questionnaires throughout the study.'}, {'measure': 'Perceived immune system support', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, and Week 16', 'description': 'Participants will rate their perception of immune system support using self-administered questionnaires during the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sore-throat', 'Common Cold']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be male or female\n* Be aged 18-65\n* Meet at least one of the following criteria:\n\nWork in a hospital or other healthcare setting Work in a school\n\n* Have a child/children under the age of 10\n* Be willing to take the test or placebo product once daily and complete study questionnaires every four weeks for the 16-week study period\n* 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.\n* Be willing to maintain their current diet, sleep schedule, and activity level for the duration of the study.\n* Be in good general health and not live with any uncontrolled chronic conditions.\n* Reside in the United States.\n\nExclusion Criteria:\n\n* Has undergone any surgeries or invasive treatments in the past six months or plans to undergo any during the study period\n* Anyone with seasonal allergies\n* Anyone who follows a restrictive diet (e.g., keto, vegan, raw, carnivore, etc.).\n* Anyone who got a vaccination in the last 2 weeks.\n* Anyone taking one or more prescription medications:\n\nCorticosteroids: 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)\n\n* Has had any major illness in the past three months.\n* Drinks heavily (defined as 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).\n* Uses illicit drugs.\n* Has known allergies or hypersensitivities to any of the study product ingredients.\n* Is immunocompromised due to a medical condition or due to immunosuppressive medications or treatments.\n* Has any known autoimmune conditions.\n* Has any chronic health conditions that could impact participation in the study, including cancer, liver, or mental health disorders.\n* Has known serious allergic reactions requiring the use of an Epi-Pen.\n* Is currently pregnant, trying to conceive, or breastfeeding.\n* Is currently participating in another research study or plans to do so during the 16-week study period.\n* Has a history of substance abuse.\n* Is currently a smoker or has been a smoker in the past three months.'}, 'identificationModule': {'nctId': 'NCT07246850', 'briefTitle': 'A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Throat Spray on the Incidence and Duration of Sickness', 'organization': {'class': 'INDUSTRY', 'fullName': "Beekeeper's Naturals Inc"}, 'officialTitle': 'A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Throat Spray on the Incidence and Duration of Sickness', 'orgStudyIdInfo': {'id': '20694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Beekeeper's Propolis Throat Spray", 'interventionNames': ["Dietary Supplement: Beekeeper's Propolis Throat Spray"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Throat Spray', 'interventionNames': ['Dietary Supplement: Placebo Throat Spray']}], 'interventions': [{'name': "Beekeeper's Propolis Throat Spray", 'type': 'DIETARY_SUPPLEMENT', 'description': "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.", 'armGroupLabels': ["Beekeeper's Propolis Throat Spray"]}, {'name': 'Placebo Throat Spray', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will administer four sprays of a placebo throat spray into the back of the mouth once daily in the morning for 16 weeks.', 'armGroupLabels': ['Placebo Throat Spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89118', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beekeeper's Naturals Inc", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}