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

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.

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.

Study Overview

• Status: Completed
• Conditions: Immune Response; Respiratory Diseases
• Intervention / Treatment: Combination product: Combination of plant extracts (BSL_EP027); Combination product: Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18011
    • Claret Nursing home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory infection symptoms	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)	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the respiratory infection symptoms	Duration of the respiratory infection symptoms (days)	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Medication for the respiratory infection symptoms	Type of medication for the respiratory infection symptoms	16 weeks
Dose of the Medication for the respiratory infection symptoms	Dose of the medical treatment for the respiratory infection symptoms	16 weeks
Duration of the medical treatment for the respiratory infection symptoms	Duration of the medical treatment for the respiratory infection symptoms	16 weeks

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Carlos Gracián, MD, Doctor of the Claret Nursing Home (Granada, Spain)

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Plant extracts; Immunostimulation; Respiratory diseases
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: C027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No