NCT06573814已完成2 期
A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Bio Gelee Royale Forte on Immune Health in Healthy Adults
Medex d.o.o.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The difference in frequency, severity, and duration of upper respiratory tract infections (URTI).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •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
排除标准
- •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))
- •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
结局指标
主要结局
The difference in frequency, severity, and duration of upper respiratory tract infections (URTI).
时间窗: 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.
次要结局
- The difference in frequency of URTIs from day -14 to day -1.(day -14 to day -1)
- The difference in frequency of URTIs from day -14 to day 84.(day -14 to day 84)
- Severity of URTI symptoms over the 84-day supplementation period.(baseline to day 84)
- The difference in proportion of participants with incidence of URTIs from day -14 to day -1.(day -14 to day -1)
- The difference in proportion of participants with incidence of URTIs from baseline to day 84.(baseline to day 84)
- The difference in duration of URTI symptoms from day -14 to day -1.(day -14 to day 84)
- The difference in number of sick days from day -14 to day -1.(day -14 to day -1)
- The difference in number of sick days from day -14 to day 84.(day -14 to day 84)
- The difference in duration of URTI symptoms from day -14 to day 84.(day -14 to day 84)
- Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day 84.(day -14 to day 84)
- The difference in proportion of participants with incidence of URTIs from day -14 to day 84.(day -14 to 84)
- Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between baseline to day 84.(baseline to day 84)
- The difference in number of sick days from baseline to day 84.(baseline to day 84)
- Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day -1.(day -14 to day -1)
- The difference in severity of URTI symptoms from day -14 to day -1.(day -14 to day -1)
- The difference in severity of URTI symptoms from day -14 to day 84.(day -14 to day 84)
研究者
研究点 (2)
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