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Dietary Supplement

Bio Gelee Royale Forte for Common Cold

Phase 2

Recruiting

Led By David Crowley, PhD

Research Sponsored by Medex d.o.o.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Males and females between 18-65 years of age, inclusive

2. 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -14 to 84

Summary

This trial aims to test the safety and effectiveness of Bio Gelee Royale Forte compared to a placebo in reducing the frequency, severity, and duration of common colds and flu in healthy adults who are

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Bio Gelee Royale Forte are being studied but may include reactions similar to those experienced with other supplements aimed at boosting immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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

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I am using a hormonal contraceptive method.

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My partner had a vasectomy over 6 months ago.

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I have had at least two upper respiratory tract infections in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -14 to 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -14 to 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -14 to 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The difference in frequency, severity, and duration of upper respiratory tract infections (URTI).

Secondary study objectives

Severity of URTI symptoms over the 84-day supplementation period.

The difference in duration of URTI symptoms from day -14 to day -1.

The difference in duration of URTI symptoms from day -14 to day 84.

+13 more

Other study objectives

Incidence of post-emergent adverse effects between day -14 to day 84.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bio Gelee Royale ForteExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention

0 / 5Eligibility criteria met