Upper Respiratory Tract InfectionPhase 2NCT06573814
The Effects of Bio Gelee Royale Forte on Immune Health in Healthy Adults
A Phase 2 study testing Bio Gelee Royale Forte in people with Upper Respiratory Tract Infection and URTI, run by Medex d.o.o. at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the safety and efficacy of Bio Gelee Royale Forte compared to placebo on frequency, severity, and duration of upper respiratory tract infections (URTIs) among adults who are otherwise healthy but susceptible to URTIs during cold and flu season. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection, URTI
- What is being tested?
- Bio Gelee Royale Forte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2024to 1 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 18-65 years of age, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Individuals of child-bearing potential must self-report confirmation they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
Show all 16Show fewer
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing 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 immunity support) as much as possible throughout the study and not add new supplements to their 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 diagnosed medical conditions
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational 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 study period 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 pulmonary disease (COPD))
Show all 23Show fewer
- 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 planned surgery during the course of the study
- Self-reported cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in 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 that may 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's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Bio Gelee Royale Forte on Immune Health in Healthy Adults
The objective of this study is to evaluate the safety and efficacy of Bio Gelee Royale Forte compared to placebo on frequency, severity, and duration of upper respiratory tract infections (URTIs) among adults who are otherwise healthy but susceptible to URTIs during cold and flu season. Additionally, the safety and tolerability of Bio Gelee Royale Forte, as compared to placebo, will be measured by the occurrence of and/or changes in treatment emergent adverse effects.
Read the detailed description
The investigational product (IP), Bio Gelee Royale Forte, contains royal jelly which is secreted by the hypopharyngeal and mandibular glands of nurse bees. Royal jelly is commonly used as a functional food due to its antibacterial, anti-oxidant, anti-inflammatory, and anti-aging properties. While current evidence suggests royal jelly may play a role in improving human health, little is known about the effects of royal jelly on immune function. Therefore, the objective of this study is to investigate the efficacy of Bio Gelee Royale Forte compared to placebo on immune health in a healthy adult population with self-reported susceptibility to URTIs during cold and flu season.
- Conditions
- Upper Respiratory Tract Infection, URTI
- Being tested
- Bio Gelee Royale Forte, Placebo
- Keywords
- Upper Respiratory Tract Infection, Safety and efficacy, Royal Jelly
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio Gelee Royale ForteDietary supplement
Also called Royal Jelly
Two capsules of Bio Gelee Royale Forte will be taken in the morning on empty stomach once per day for 98 days.
PlaceboOther
Two capsules of placebo will be taken in the morning on empty stomach once per day for 98 days.
| Study group | Role | What they receive |
|---|---|---|
| Bio Gelee Royale Forte | Experimental | Participants will be instructed to take two capsules of study product in the morning on empty stomach once per day for 98 days. If there is an incidence of URTI between enrollment and Day-14, participant will be instructed to start study product intake three days after symptom resolution. If a dose is missed participants are instructed to take the dose approximately two hours after a meal. Participants will be advised not to exceed two capsules daily. Receives: Dietary Supplement: Bio Gelee Royale Forte |
| Placebo | Placebo comparator | Participants will be instructed to take two capsules of study product in the morning on empty stomach once per day for 98 days. If there is an incidence of URTI between enrollment and Day-14, participant will be instructed to start study product intake three days after symptom resolution. If a dose is missed participants are instructed to take the dose approximately two hours after a meal. Participants will be advised not to exceed two capsules daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in frequency, severity, and duration of upper respiratory tract infections (URTI).
The difference in frequency, severity, and duration of URTIs as assessed by the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire over the 84-day supplementation period between Bio Gelee Royale Forte and Placebo. The average severity score of each symptom is scored on scale of 0- no symptom to 7-severe symptom. A higher score would indicate worse outcome.
Measured: Day -14 to day 84
Secondary outcomes (18)
The difference in frequency of URTIs from day -14 to day -1.
The difference in frequency of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire, will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day -1
The difference in frequency of URTIs from day -14 to day 84.
The difference in frequency of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day 84
The difference in severity of URTI symptoms from day -14 to day -1.
The difference in severity of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire and determined by the average severity scores of URTI symptoms will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day -1
The difference in severity of URTI symptoms from day -14 to day -1.
The difference in severity of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire and determined by the area under the curve (AUC) for daily total symptom scores will be compared between Bio Gelee Royale Forte and Placebo. Area under the curve (AUC) for URTI symptoms from WURSS-24 is calculated daily from day -14 to day -1.
Measured: day -14 to day -1
The difference in severity of URTI symptoms from day -14 to day 84.
The difference in severity of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire and determined by the average severity scores of URTI symptoms will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day 84
The difference in severity of URTI symptoms from day -14 to day 84.
The difference in severity of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire and determined by the area under the curve (AUC) for daily total symptom scores will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day 84
The difference in duration of URTI symptoms from day -14 to day -1.
The difference in duration of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day 84
The difference in duration of URTI symptoms from day -14 to day 84.
The difference in duration of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day 84
Severity of URTI symptoms over the 84-day supplementation period.
Severity of URTI symptoms over the 84-day supplementation period as determined by the average severity score of URTI symptoms. The average severity score of each symptom is scored on scale of 0- no symptom to 7-severe symptom. A higher score would indicate worse outcome.
Measured: baseline to day 84
The difference in proportion of participants with incidence of URTIs from day -14 to day -1.
The difference in proportion of participants with incidence of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day -1
The difference in proportion of participants with incidence of URTIs from baseline to day 84.
The difference in proportion of participants with incidence of URTIs from baseline to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: baseline to day 84
The difference in proportion of participants with incidence of URTIs from day -14 to day 84.
The difference in proportion of participants with incidence of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to 84
The difference in number of sick days from day -14 to day -1.
The difference in number of sick days from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day -1
The difference in number of sick days from baseline to day 84.
The difference in number of sick days from baseline to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: baseline to day 84
The difference in number of sick days from day -14 to day 84.
The difference in number of sick days from day -14 to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day 84
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day -1.
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day -1 will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day -1
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between baseline to day 84.
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between baseline to day 84 will be compared between Bio Gelee Royale Forte and Placebo.
Measured: baseline to day 84
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day 84.
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day 84 will be compared between Bio Gelee Royale Forte and Placebo.
Measured: day -14 to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start25 Oct 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medex d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Crowley, PhD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573814
- Sponsor's protocol ID
- 24MDCFR01
- Status last verified
- Apr 2025
- First submitted
- 20 Aug 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Bio Gelee Royale Forte on Immune Health in Healthy Adults
- ClinicalTrials.gov ID
- NCT06573814
- Acronym / sponsor ID
- 24MDCFR01
- Conditions
- Upper Respiratory Tract Infection, URTI
- Keywords
- Upper Respiratory Tract Infection, Safety and efficacy, Royal Jelly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medex d.o.o.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of Bio Gelee Royale Forte compared to placebo on frequency, severity, and duration of upper respiratory tract infections (URTIs) among adults who are otherwise healthy but susceptible to URTIs during cold and flu season. Additionally, the safety and tolerability of Bio Gelee Royale Forte, as compared to placebo, will be measured by the occurrence of and/or changes in treatment emergent adverse effects.
Detailed description
The investigational product (IP), Bio Gelee Royale Forte, contains royal jelly which is secreted by the hypopharyngeal and mandibular glands of nurse bees. Royal jelly is commonly used as a functional food due to its antibacterial, anti-oxidant, anti-inflammatory, and anti-aging properties. While current evidence suggests royal jelly may play a role in improving human health, little is known about the effects of royal jelly on immune function. Therefore, the objective of this study is to investigate the efficacy of Bio Gelee Royale Forte compared to placebo on immune health in a healthy adult population with self-reported susceptibility to URTIs during cold and flu season.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio Gelee Royale Forte | Experimental | Dietary Supplement: Bio Gelee Royale ForteParticipants will be instructed to take two capsules of study product in the morning on empty stomach once per day for 98 days. If there is an incidence of URTI between enrollment and Day-14, participant will be instructed to start study product intake three days after symptom resolution. If a dose is missed participants are instructed to take the dose approximately two hours after a meal. Participants will be advised not to exceed two capsules daily. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be instructed to take two capsules of study product in the morning on empty stomach once per day for 98 days. If there is an incidence of URTI between enrollment and Day-14, participant will be instructed to start study product intake three days after symptom resolution. If a dose is missed participants are instructed to take the dose approximately two hours after a meal. Participants will be advised not to exceed two capsules daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females between 18-65 years of age, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Individuals of child-bearing potential must self-report confirmation they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- At least two self-reported incidences of URTI in the last 12 months
Key exclusion criteria (23 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational 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 study period requiring medication or need for allergy shots
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio Gelee Royale ForteAlso: Royal JellyTwo capsules of Bio Gelee Royale Forte will be taken in the morning on empty stomach once per day for 98 days. | Dietary supplement | Bio Gelee Royale Forte |
| PlaceboTwo capsules of placebo will be taken in the morning on empty stomach once per day for 98 days. | Other | Placebo |
Primary outcome
The difference in frequency, severity, and duration of upper respiratory tract infections (URTI).
Time frame: Day -14 to day 84
The difference in frequency, severity, and duration of URTIs as assessed by the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire over the 84-day supplementation period between Bio Gelee Royale Forte and Placebo. The average severity score of each symptom is scored on scale of 0- no symptom to 7-severe symptom. A higher score would indicate worse outcome.
18 secondary outcomes
The difference in frequency of URTIs from day -14 to day -1.
Time frame: day -14 to day -1
The difference in frequency of URTIs from day -14 to day 84.
Time frame: day -14 to day 84
The difference in severity of URTI symptoms from day -14 to day -1.
Time frame: day -14 to day -1
The difference in severity of URTI symptoms from day -14 to day -1.
Time frame: day -14 to day -1
The difference in severity of URTI symptoms from day -14 to day 84.
Time frame: day -14 to day 84
The difference in severity of URTI symptoms from day -14 to day 84.
Time frame: day -14 to day 84
The difference in duration of URTI symptoms from day -14 to day -1.
Time frame: day -14 to day 84
The difference in duration of URTI symptoms from day -14 to day 84.
Time frame: day -14 to day 84
Severity of URTI symptoms over the 84-day supplementation period.
Time frame: baseline to day 84
The difference in proportion of participants with incidence of URTIs from day -14 to day -1.
Time frame: day -14 to day -1
The difference in proportion of participants with incidence of URTIs from baseline to day 84.
Time frame: baseline to day 84
The difference in proportion of participants with incidence of URTIs from day -14 to day 84.
Time frame: day -14 to 84
The difference in number of sick days from day -14 to day -1.
Time frame: day -14 to day -1
The difference in number of sick days from baseline to day 84.
Time frame: baseline to day 84
The difference in number of sick days from day -14 to day 84.
Time frame: day -14 to day 84
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day -1.
Time frame: day -14 to day -1
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between baseline to day 84.
Time frame: baseline to day 84
Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day 84.
Time frame: day -14 to day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, PhD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bio Gelee Royale Forte in people with Upper Respiratory Tract Infection and URTI, run by Medex d.o.o. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in frequency, severity, and duration of upper respiratory tract infections (URTI). (time frame: Day -14 to day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.