NCT07642648尚未招募2 期
A Randomized Blinded Controlled Trial Evaluating the Efficacy of a Novel Herbal Cold and Flu Blend in Reducing the Duration and Severity of Symptoms of the Common Cold
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
研究概览
简要总结
The aim of this study is to evaluate the efficacy of a Novel Herbal Cold & Flu Blend in reducing the duration of symptoms of the common cold. The secondary objective is to assess whether the investigational product reduces the severity of symptoms. Participants will be enrolled for 16 weeks, during this period they will take the assigned study product when they experience URTI symptoms.
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
- Quadruple (Participant, Care Provider, 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
- •Adults aged 18-65 years living in Australia
- •Individuals with a history of recurrent Upper Respiratory Tract infections (URTI) (at least one episode per year)
- •Able to provide informed consent
- •Generally healthy
- •Agree to not participate in another clinical trial while enrolled in this trial
- •Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period
- •Females of childbearing potential must use a prescribed form of birth control (e.g. oral contraceptive)
排除标准
- •Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, autoimmune conditions, neurological disorders such as multiple sclerosis.
- •Unstable illness e.g., changing medication/treatment.
- •BMI <18.5, >30
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- •Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
- •Active smokers, nicotine use (including vaping/e-cigarettes) or drug (prescription or illegal substances) abuse
- •Current alcohol use (>21 alcoholic drinks week)
- •Allergic to any of the ingredients in the active or placebo formula
- •Allergic to plants in the Asteraceae family
- •Pregnant or lactating woman
- •Regular use of medications that would affect the immune and/or the inflammatory response e.g. antihistamines, anti-inflammatories, immunosuppressants, steroids excluding topical steroid use.
- •Use of anticoagulant medications such as warfarin.
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
- •Participants with allergic rhinitis
- •Regular use of antihistamines
- •Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.
研究者
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