Preliminary Study on the Effect of Consuming a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Living in a Nursing Home.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Respiratory infection symptoms
研究概览
简要总结
The objective of the present study is to evaluate the effectiveness of daily consumption of a Combination of Plant Extracts (BSL_EP027) on the incidence of respiratory infection symptoms and their duration in older healthy volunteers living in a nursing home.
详细描述
A prevalence of deficient immune state is estimated at 44% of the world's population, a figure that rises in the senior population group.
Traditionally, protection against infection and improvement of the immune response has been addressed through the use of plant extracts. An effective immune response involves the action of both innate and specific responses and the perfect coordination between both. Natural strategies that can activate both types of immune response can lead to more effective treatments.
Our hypothesis is that the different effects of the combination of several plant extracts can lead to a synergy that generates a more effective product in the prevention of respiratory infections, especially in susceptible populations such as the elderly.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living in a nursing home with medical service.
- •Freely accept to participate in the study and sign the informed consent document.
排除标准
- •Having a disease that affects the development and results of the study.
- •Suffer alterations of the state of health incompatible with the continuity in the study.
- •Suffer any adverse event not tolerated by the subject.
研究组 & 干预措施
Combination of plant extracts (BSL_EP027)
Volunteers will dissolve in water a sachet per day with the Combination of plant extracts (BSL_EP027), and maltodextrin.
干预措施: Combination of plant extracts (BSL_EP027) (Combination Product)
Placebo
Volunteers will dissolve in water a sachet per day with maltodextrin.
干预措施: Placebo (Combination Product)
结局指标
主要结局
Respiratory infection symptoms
时间窗: 16 weeks
Incidence of respiratory infection symptoms (fiber, cough, rinitis, headache, sore throat, bone and/or muscle pain, fatigue/exhaustion, nausea and/or vomiting, lack of appetite and /or trouble for sleeping)
次要结局
- Duration of the respiratory infection symptoms(16 weeks)