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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04386408
Other study ID # C027
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
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