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

Biosearch Life

Status and phase: Completed; Phase 1

Conditions: Immune Response; Respiratory Diseases

Treatments: Combination Product: Placebo; Combination Product: Combination of plant extracts (BSL_EP027)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04386408

C027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Combination of plant extracts (BSL_EP027)

Experimental group

Description:

Volunteers will dissolve in water a sachet per day with the Combination of plant extracts (BSL_EP027), and maltodextrin.

Treatment:

Combination Product: Combination of plant extracts (BSL_EP027)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Combination Product: Placebo