Amunizer for Immune Support: A Randomized, Placebo Controlled, Double Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of days with symptoms documented by the Franklin Health Immune Inventory (FHII)
研究概览
简要总结
Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Similar beverage without the probiotics and botanicals
干预措施: Placebo (Other)
Intervention
Herbal and probiotic beverage
干预措施: Amunizer (Dietary Supplement)
结局指标
主要结局
Number of days with symptoms documented by the Franklin Health Immune Inventory (FHII)
时间窗: from baseline to the end of the study, 8 weeks
The FHII measures incidence and severity of over 50 signs of immune health. Days with symptoms will range from 0 to 56 days, indicating no sickness to sick every day.
Severity of symptoms documented by the FHII
时间窗: from baseline to the end of the study, 8 weeks
The FHII measures incidence and severity of over 50 signs of immune health. Symptom severity is measured on a likert scale with higher scores indicating greater symptom severity.
次要结局
- Incidence and severity on the upper respiratory symptom subscale of the FHII(from baseline to the end of the study, 8 weeks)
- Incidence and severity on the dermal symptom subscale of the FHII(from baseline to the end of the study, 8 weeks)
- Change from baseline scores on the Franklin Sleep Quality Inventory(8 week)
- Change from baseline scores on the Franklin Mood Scale(8 week)
- Incidence and severity on the gastrointestinal symptom subscale of the FHII(from baseline to the end of the study, 8 weeks)
- Change from baseline scores on the Franklin Energy Level Inventory(8 week)
研究者
Jessie Hawkins
President
Franklin Health Research