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

Immune Response Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386408
• Other study ID #: C027
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immune Response
• Respiration Disorders
• Respiratory Diseases
• Respiratory Tract Diseases
• Respiratory Tract Infections

Intervention

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
Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.

Locations

Country	Name	City	State
Spain	Claret Nursing home	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type of Medication for the respiratory infection symptoms	Type of medication for the respiratory infection symptoms	16 weeks
Other	Dose of the Medication for the respiratory infection symptoms	Dose of the medical treatment for the respiratory infection symptoms	16 weeks
Other	Duration of the medical treatment for the respiratory infection symptoms	Duration of the medical treatment for the respiratory infection symptoms	16 weeks
Primary	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	Duration of the respiratory infection symptoms	Duration of the respiratory infection symptoms (days)	16 weeks