Immune Response, Respiratory Diseases
Conditions
Keywords
Immunostimulation, Respiratory diseases, Plant extracts
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTCombination of plant extracts (BSL_EP027)
Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.
COMBINATION_PRODUCTPlacebo
Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Living in a nursing home with medical service. * Freely accept to participate in the study and sign the informed consent document.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory infection symptoms | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the respiratory infection symptoms | 16 weeks | Duration of the respiratory infection symptoms (days) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of the medical treatment for the respiratory infection symptoms | 16 weeks | Duration of the medical treatment for the respiratory infection symptoms |
| Type of Medication for the respiratory infection symptoms | 16 weeks | Type of medication for the respiratory infection symptoms |
| Dose of the Medication for the respiratory infection symptoms | 16 weeks | Dose of the medical treatment for the respiratory infection symptoms |
Countries
Spain
Outcome results
None listed