Joint DiseasesPhase 1/2NCT04029792
Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility
A Phase 1/2 study testing Combination of plant extracts (BSL_EP028) in people with Joint Diseases, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Diseases
- What is being tested?
- Combination of plant extracts (BSL_EP028)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2019to 15 Oct 2020
- Phase
- Phase 1/2
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women that have joint discomfort (WOMAC score >20)
Who cannot join
- Consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations).
- Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist
- Consuming nutritional supplements containing antioxidant substances
- Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain.
- Being unable to perform the physical tests required in the study.
- Have an allergy to some component of the study product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP028) on Joint Mobility, Physical Performance and Vitality
The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.
Read the detailed description
The natural aging process involves several body changes that can affect to the mobility of subjects. Among them, those that affect the joints may have the greatest impact on mobility. With age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. This joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. Therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. All of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care.
For all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. In this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.
- Conditions
- Joint Diseases
- Being tested
- Combination of plant extracts (BSL_EP028), Placebo
- Keywords
- Plant extract, Joint Mobility, Physical performance, Vitality
- Medical subject headings
- Joint 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_EP028)Combination product
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
PlaceboCombination product
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Plant Extracts (BSL_EP028) | Experimental | Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028) Receives: Combination Product: Combination of plant extracts (BSL_EP028) |
| Placebo | Placebo comparator | Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test
It is a questionnaire consisting of 24 items divided into 3 subscales:
- Pain (5 items)
- Stiffness (2 items)
- Physical Function (17 items) The higher the score, the higher the amount of pain, stiffness, and a high level of functional limitations
Measured: 8 weeks
Secondary outcomes (2)
SF-36 Vitality score
Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality)
Measured: 8 weeks
Physical activity measurement
Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start15 Oct 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helios Pareja Galeano, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029792
- Sponsor's protocol ID
- C028
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP028) on Joint Mobility, Physical Performance and Vitality
- ClinicalTrials.gov ID
- NCT04029792
- Acronym / sponsor ID
- C028
- Conditions
- Joint Diseases
- Keywords
- Plant extract, Joint Mobility, Physical performance, Vitality
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 23 Jul 2019 (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 aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.
Detailed description
The natural aging process involves several body changes that can affect to the mobility of subjects. Among them, those that affect the joints may have the greatest impact on mobility. With age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. This joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. Therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. All of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care.
For all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. In this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.
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_EP028) | Experimental | Combination Product: Combination of plant extracts (BSL_EP028)Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028) |
| Placebo | Placebo comparator | Combination Product: PlaceboVolunteers will take twice at day for 8 weeks a capsule containing maltodextrin. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women that have joint discomfort (WOMAC score >20)
Key exclusion criteria (6 listed)
- Consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations).
- Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist
- Consuming nutritional supplements containing antioxidant substances
- Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain.
- Being unable to perform the physical tests required in the study.
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_EP028)Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. | Combination product | Combination of Plant Extracts (BSL_EP028) |
| PlaceboEach participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. | Combination product | Placebo |
Primary outcome
Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test
Time frame: 8 weeks
It is a questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items) * Stiffness (2 items) * Physical Function (17 items) The higher the score, the higher the amount of pain, stiffness, and a high level of functional limitations
2 secondary outcomes
SF-36 Vitality score
Time frame: 8 weeks
Physical activity measurement
Time frame: 8 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 6 Oct 2026.
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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.
Helios Pareja Galeano principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combination of plant extracts (BSL_EP028) in people with Joint 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 1 inclusion and 6 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 6 Oct 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test (time frame: 8 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 6 Oct 2026.