Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Primary Objective: Reduction in severity of common cold symptoms
研究概览
简要总结
A randomized-controlled interventional clinical trial to evaluate the effectiveness of EZC Pak & EZC Pak+D for the treatment of the common cold and/or a URI.
详细描述
This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the efficacy of PPC Pharmaceuticals EZC Pak (& EZC Pak+D) to improve the severity and duration of the common cold or a URI in individuals. It is hypothesized that study participants will experience a positive impact on the duration and severity of their cold/URI while using EZC Pak (&EZC Pak+D). The second study objective is to examine if patients are accepting the test product as an alternative to antibiotics.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female over 18 years old
- •Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- •Seeking OTC remedies to reduce the severity and duration of their common cold symptoms, when they arise
- •Must have a thermometer at home
- •Must have a blood pressure monitor at home
- •Ideally, uses one of the following devices: Apple Watch, Oura Ring, FitBit, other fitness trackers
排除标准
- •Unwilling to try the test product for their cold
- •Has any of the following medical conditions:
- •ragweed or daisy allergy
- •chronic seasonal allergies
- •liver disease
- •autoimmune or connective tissue disorder (e.g., rheumatoid arthritis, lupus, multiples sclerosis, HIV)
- •alcohol consumption more than 7 drinks per week, or more than 3 drinks per occasion
- •IV drug use
- •renal disease
- •females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
结局指标
主要结局
Primary Objective: Reduction in severity of common cold symptoms
时间窗: 6 months
The primary objective of this study is to understand if EZC Pak (and EZC Pak +D) changes the severity and duration of an upper respiratory illness (URI) compared to a placebo. The study uses a scale of 1-4 (no symptoms to severe symptoms) to assess the effectiveness of the intervention.
次要结局
未报告次要终点