Evaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immune Response Respiratory Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Combination of plant extracts (BSL_EP027)

Intervention Type COMBINATION_PRODUCT

Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.

Placebo

Volunteers will dissolve in water a sachet per day with maltodextrin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.

Interventions

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Combination 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.

Intervention Type COMBINATION_PRODUCT

Placebo

Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes