Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Bronchitis (Pediatric)
Treatment
Placebo
Bio Gelee Royale Forte
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females between 18-65 years of age, inclusive
Females not of child-bearing potential, defined as those who have undergone asterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tuballigation, complete endometrial ablation) or have been post-menopausal for at least 1year prior to screening Or, Individuals of child-bearing potential must self-report confirmation they are notpregnant, do not plan to become pregnant, and agree to use a medically approvedmethod of birth control for the duration of the study. All hormonal birth controlmust have been in use for a minimum of three months. Acceptable methods of birthcontrol include:
Hormonal contraceptives including oral contraceptives, hormone birth controlpatch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectablecontraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Intrauterine devices
Non-heterosexual lifestyle or agrees to use contraception if planning onchanging to heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
Abstinence
At least two self-reported incidences of URTI in the last 12 months
Agrees to maintain current lifestyle as much as possible throughout the study,including diet, exercise, and sleep
Agrees to maintain medications/supplements (particularly those used for immunitysupport) as much as possible throughout the study and not add new supplements totheir routine
Able and willing to complete all study assessments
Provided voluntary and informed consent to participate in the study
Generally healthy as determined by medical history with no unstable diagnosedmedical conditions
Exclusion
Exclusion Criteria:
Individuals who are pregnant, breast feeding, or planning to become pregnant duringthe study
Allergy, sensitivity, intolerance, or dietary restriction preventing consumption ofinvestigational product or placebo ingredients
Self-reported allergy to bees or other insects
Self-reported autoimmune disease or are immune compromised due to other factors
Self-reported current or anticipated severe environmental allergies during the studyperiod requiring medication or need for allergy shots
Self-reported ongoing diagnosis of acute or chronic respiratory illness (e.g.,asthma, chronic bronchitis, sinusitis, pharyngitis, chronic obstructive pulmonarydisease (COPD))
Self-reported ongoing and unstable diseases/conditions in the past three months,including:
Arthritis and joint diseases
Gastrointestinal diseases
Hypertension
Type I or type II diabetes
Cardiovascular disease
Kidney diseases
Liver diseases
Thyroid condition
Self-reported surgery in the past three months or individuals who have plannedsurgery during the course of the study
Self-reported cancer, except skin basal cell carcinoma completely excised with nochemotherapy or radiation with a follow up that is negative. Volunteers with cancerin full remission for more than five years after diagnosis are acceptable
Alcohol intake average of >2 standard drinks per day
Alcohol or drug abuse within the last 12 months that has required treatment
Current use of prescribed and/or over-the-counter (OTC) medications/supplements thatmay impact the efficacy and/or safety of the investigational product
Participation in other clinical research studies 30 days prior to screening
Individuals who are unable to give informed consent
Any other condition or lifestyle factor that may adversely affect the participant'sability to complete the study or its measures or pose significant risk to theparticipant
Study Design
Study Description
Connect with a study center
KGK Science Inc.
London, Ontario N6B3L1
CanadaActive - Recruiting
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