Immune ResponsePhase 1NCT04386408
Evaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections
A Phase 1 study testing Combination of plant extracts (BSL_EP027) in people with Immune Response and Respiratory Diseases, run by Biosearch S.A. at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Response, Respiratory Diseases
- What is being tested?
- Combination of plant extracts (BSL_EP027)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2019to 31 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Living in a nursing home with medical service.
- Freely accept to participate in the study and sign the informed consent document.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Immune Response, Respiratory Diseases
- Being tested
- Combination of plant extracts (BSL_EP027), Placebo
- Keywords
- Immunostimulation, Respiratory diseases, Plant extracts
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Combination of plant extracts (BSL_EP027) | Experimental | Volunteers will dissolve in water a sachet per day with the Combination of plant extracts (BSL_EP027), and maltodextrin. Receives: Combination Product: Combination of plant extracts (BSL_EP027) |
| Placebo | Placebo comparator | Volunteers will dissolve in water a sachet per day with maltodextrin. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 weeks
Secondary outcomes (1)
Duration of the respiratory infection symptoms
Duration of the respiratory infection symptoms (days)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start30 Nov 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gracián, MD, Principal investigator, Doctor of the Claret Nursing Home (Granada, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386408
- Sponsor's protocol ID
- C027
- Status last verified
- Jul 2019
- First submitted
- 14 Nov 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04386408
- Acronym / sponsor ID
- C027
- Conditions
- Immune Response, Respiratory Diseases
- Keywords
- Immunostimulation, Respiratory diseases, Plant extracts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of plant extracts (BSL_EP027) | Experimental | Combination Product: 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 comparator | Combination Product: PlaceboVolunteers will dissolve in water a sachet per day with maltodextrin. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Living in a nursing home with medical service.
- Freely accept to participate in the study and sign the informed consent document.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Combination of plant extracts (BSL_EP027) |
| PlaceboEach participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life. | Combination product | Placebo |
Primary outcome
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)
1 secondary outcome
Duration of the respiratory infection symptoms
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gracián, MD principal investigator
Doctor of the Claret Nursing Home (Granada, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination of plant extracts (BSL_EP027) in people with Immune Response and Respiratory Diseases, run by Biosearch S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory infection symptoms (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.