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

Phase 1

Completed

• Conditions: Immune Response; Respiratory Diseases
• Interventions: Combination Product: Combination of plant extracts (BSL_EP027); Combination Product: Placebo

• Registration Number: NCT04386408
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-11-14
• Study Start: 2019-11-30
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of plant extracts (BSL_EP027)	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.
Placebo	Placebo	Volunteers will dissolve in water a sachet per day with maltodextrin.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Duration of the respiratory infection symptoms	16 weeks	Duration of the respiratory infection symptoms (days)

Trial Locations

Locations (1)

Claret Nursing home; 🇪🇸 Granada, Spain