Skip to main content
OpenTrials
Completed

NCT Number: NCT04386408

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immune Response Respiratory Diseases Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Claret Nursing home

Granada, 18011, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination of plant extracts (BSL_EP027)

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

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.

Primary outcomes

  1. Respiratory infection symptoms

    Time frame: 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 outcomes

  1. Duration of the respiratory infection symptoms

    Time frame: 16 weeks

    Duration of the respiratory infection symptoms (days)

Other outcomes

  1. Type of Medication for the respiratory infection symptoms

    Time frame: 16 weeks

    Type of medication for the respiratory infection symptoms

  2. Dose of the Medication for the respiratory infection symptoms

    Time frame: 16 weeks

    Dose of the medical treatment for the respiratory infection symptoms

  3. Duration of the medical treatment for the respiratory infection symptoms

    Time frame: 16 weeks

    Duration of the medical treatment for the respiratory infection symptoms

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.