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

Sponsor

Biosearch S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT04386408

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

29.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Response Respiratory Diseases	Combination Product: Combination of plant extracts (BSL_EP027) Combination Product: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Nov 30, 2019

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Combination Product: 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.
Placebo Comparator: Placebo Volunteers will dissolve in water a sachet per day with maltodextrin.	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.

Arm

Intervention/Treatment

Experimental: 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.

Combination Product: 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.

Placebo Comparator: Placebo

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

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Duration of the respiratory infection symptoms [16 weeks]
Duration of the respiratory infection symptoms (days)

Other Outcome Measures

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
Duration of the medical treatment for the respiratory infection symptoms [16 weeks]
Duration of the medical treatment for the respiratory infection symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.