Bio Gelee Royale Forte for Common Cold

Recruiting in Palo Alto (17 mi)

Overseen by David Crowley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Medex d.o.o.

Must not be taking: Allergy medications

Disqualifiers: Pregnancy, Autoimmune, Respiratory illness, others

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to maintain their current medications and supplements, especially those used for immunity support, and not add new supplements to their routine.

What data supports the effectiveness of the treatment Bio Gelee Royale Forte for the common cold?

Research on royal jelly, a component of Bio Gelee Royale Forte, shows it can help reduce inflammation, which might be beneficial for common cold symptoms. Additionally, studies on similar supplements like vitamin C and zinc have shown some effectiveness in reducing cold symptoms. ^{1 2 3 4 5}

Is Bio Gelee Royale Forte safe for human use?

There is no specific safety data available for Bio Gelee Royale Forte or its related names in the provided research articles. ^{6 7 8 9 10}

How is Bio Gelee Royale Forte different from other treatments for the common cold?

Bio Gelee Royale Forte, a royal jelly supplement, is unique because it contains bioactive substances with antiviral, anti-inflammatory, and immunomodulatory properties, which may help enhance the body's defense against infections like the common cold. ^{11 12 13 14 15}

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

Healthy adults aged 18-65 who have had at least two upper respiratory tract infections in the past year can join this trial. Women must not be able to bear children, either through surgery or menopause, and all participants agree to use contraception if necessary.

Inclusion Criteria

I am using two forms of birth control.

I am a woman who cannot become pregnant due to surgery or being post-menopausal for over a year.

This criterion does not apply to me.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Bio Gelee Royale Forte or placebo for 98 days to assess its effects on immune health

14 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Bio Gelee Royale Forte (Dietary Supplement)

Trial Overview The study is testing Bio Gelee Royale Forte's effects on immune health by comparing it with a placebo. It looks at how often people get sick, how bad it gets, and how long it lasts during cold season.

Participant Groups

Group I: Bio Gelee Royale Forte Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Medex d.o.o.

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

In a phase 3 clinical trial involving 207 adults, the proprietary extract 7630 from Pelargonium sidoides significantly reduced cold symptoms, with a mean decrease in cold intensity score of 11.2 points compared to 6.3 points in the placebo group by day 5 (P < .0001).

After 10 days, 90.4% of participants treated with 7630 were clinically cured, compared to only 21.2% in the placebo group, indicating that 7630 is an effective and safe treatment for the common cold.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of High-dose Pelargonium Extract in Patients With the Common Cold. Riley, DS., Lizogub, VG., Zimmermann, A., et al.[2022]

In two randomized, double-blind, placebo-controlled studies involving 130 healthy volunteers, conjugated linoleic acid (CLA) supplementation did not significantly reduce the frequency of colds caused by human rhinovirus (HRV) infection.

While CLA showed some reduction in symptom severity for cough and sore throat in one study, these effects were not consistent across both studies, indicating that larger trials are needed to fully understand CLA's potential impact on HRV-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dietary supplementation with conjugated linoleic acid on experimental human rhinovirus infection and illness. Peterson, KM., O'Shea, M., Stam, W., et al.[2011]

Health Canada is working to update regulations to allow health claims for functional foods and natural health products (NHPs), recognizing the scientific evidence supporting their health benefits.

Three key initiatives are underway: adopting U.S. health claims in Canada, developing standards for product-specific claims, and creating a regulatory framework for functional foods, which could enhance consumer access to health-related information about these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory issues related to functional foods and natural health products in Canada: possible implications for manufacturers of conjugated linoleic acid. Fitzpatrick, KC.[2023]

A total of 94 reports of adverse health events related to red yeast rice (RYR) supplements were analyzed, revealing 187 adverse drug reactions (ADRs), with the most common being musculoskeletal disorders (64 cases) and gastrointestinal issues (33 cases).

The study highlights significant safety concerns regarding RYR supplements, particularly due to the potential serious adverse effects from monacolin K, indicating a need for further research to fully understand their safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb. Vrolijk, MF., van de Koppel, S., van Hunsel, F.[2021]

A comprehensive postmarketing surveillance (PMS) system was successfully implemented for olestra (Olean), a noncaloric fat substitute, which involved collaboration with snack manufacturers and utilized specialized skills from Consumer Relations and Medical Affairs.

The PMS system effectively managed consumer reports and included a clinical studies program and an independent medical advisory panel, confirming the safety of olestra in savory snacks and providing timely data to the FDA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of new food ingredients: design and implementation of the program for the fat replacer olestra. Slough, CL., Miday, RK., Zorich, NL., et al.[2016]

The EFSA concluded that UV-treated baker's yeast, which contains up to 3.5 million IU of vitamin D per 100 grams, is safe for use in various food products, including yeast-leavened breads and food supplements.

Although the estimated vitamin D intake from this novel food could exceed the upper limit for children aged 4-10 years by 4%, the Panel believes this is unlikely due to conservative intake estimates and the broad range of food categories proposed for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of extended uses of UV-treated baker's yeast as a Novel Food pursuant to Regulation (EU) 2015/2283. Turck, D., Castenmiller, J., De Henauw, S., et al.[2021]

Royal jelly (RJ) is a highly nutritious substance with a wide range of health benefits, including anti-inflammatory, antioxidant, antitumor, and antibacterial properties, making it valuable in pharmaceuticals, food, and cosmetics.

The review highlights RJ's potential in treating inflammatory diseases like multiple sclerosis and rheumatoid arthritis, as well as its rich content of bioactive compounds that could enhance human health and warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Insights into Royal Jelly Anti-Inflammatory Properties and Related Diseases. Bagameri, L., Botezan, S., Bobis, O., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of High-dose Pelargonium Extract in Patients With the Common Cold. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanisms Underlying the Inhibition of Tyrosine Kinase Inhibitor-Induced Anorexia and Fatigue by Royal Jelly in Renal Cell Carcinoma Patients and the Correlation between Macrophage Colony Stimulating Factor and Inflammatory Mediators. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Effects of dietary supplementation with conjugated linoleic acid on experimental human rhinovirus infection and illness. [2011]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical observation on ganrening granule in treating common cold]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

A combination of high-dose vitamin C plus zinc for the common cold. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary Supplement Labels May Be Inaccurate and Misleading. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Regulatory issues related to functional foods and natural health products in Canada: possible implications for manufacturers of conjugated linoleic acid. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of new food ingredients: design and implementation of the program for the fat replacer olestra. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of extended uses of UV-treated baker's yeast as a Novel Food pursuant to Regulation (EU) 2015/2283. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

The Potential Effect of Royal Jelly on Biomarkers Related to COVID-19 Infection and Severe Progression. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Changes in hepatic gene expression associated with the hypocholesterolaemic activity of royal jelly. [2016]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Molecular Insights into Royal Jelly Anti-Inflammatory Properties and Related Diseases. [2023]

14. Japan pubmed.ncbi.nlm.nih.gov

Royal jelly supplementation improves lipoprotein metabolism in humans. [2022]

15. Croatia pubmed.ncbi.nlm.nih.gov

[Royal jelly: component efficiency, analysis, and standardisation]. [2018]