Back to resultsEvaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections
Primary Purpose
Immune Response, Respiratory Diseases
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Combination of plant extracts (BSL_EP027)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Immune Response focused on measuring Immunostimulation, Respiratory diseases, Plant extracts
Eligibility Criteria
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.
Sites / Locations
- Claret Nursing home
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Combination of plant extracts (BSL_EP027)
Placebo
Arm Description
Volunteers will dissolve in water a sachet per day with the Combination of plant extracts (BSL_EP027), and maltodextrin.
Volunteers will dissolve in water a sachet per day with maltodextrin.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Duration of the respiratory infection symptoms
Duration of the respiratory infection symptoms (days)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04386408
Brief Title
Evaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response, Respiratory Diseases
Keywords
Immunostimulation, Respiratory diseases, Plant extracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination of plant extracts (BSL_EP027)
Arm Type
Experimental
Arm Description
Volunteers will dissolve in water a sachet per day with the Combination of plant extracts (BSL_EP027), and maltodextrin.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Volunteers will dissolve in water a sachet per day with maltodextrin.
Intervention Type
Combination Product
Intervention Name(s)
Combination of plant extracts (BSL_EP027)
Intervention Description
Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Respiratory infection symptoms
Description
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)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Duration of the respiratory infection symptoms
Description
Duration of the respiratory infection symptoms (days)
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Type of Medication for the respiratory infection symptoms
Description
Type of medication for the respiratory infection symptoms
Time Frame
16 weeks
Title
Dose of the Medication for the respiratory infection symptoms
Description
Dose of the medical treatment for the respiratory infection symptoms
Time Frame
16 weeks
Title
Duration of the medical treatment for the respiratory infection symptoms
Description
Duration of the medical treatment for the respiratory infection symptoms
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Gracián, MD
Organizational Affiliation
Doctor of the Claret Nursing Home (Granada, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Claret Nursing home
City
Granada
ZIP/Postal Code
18011
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections
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