OsteoarthritisFISMEHNCT03525249
Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis
A study testing nutraceutical in people with Osteoarthritis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the efficacy of a supplement extracted from the internal membrane of the egg shell on the joint pain of patients diagnosed with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- nutraceutical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2018to 30 Sep 2018
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
- Subjects must have persistent knee pain associated with osteoarthritis with an initial score of at least 30 mm in the assessment of pain according to the EVA scale.
- The subjects should not present in their treatment narcotic drugs or steroidal anti-inflammatory or immunosuppressive drugs.
Who cannot join
- Serious or terminal illnesses.
- Subjects who are currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrates or any supplement indicated for joint health.
- Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
- Subjects with a body mass index above 32.
- Subjects with a known allergy to eggs.
- Pregnant or lactating women.
- Inability to understand informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From the Internal Membrane of the Egg Shell on the Articular Pain of Diagnosed Patients of Arthrosis
Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the efficacy of a supplement extracted from the internal membrane of the egg shell on the joint pain of patients diagnosed with osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- nutraceutical
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutraceuticalDietary supplement
Subjects will consume a capsule for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Comparator Membraflex 500mg | Experimental | experimental product one dose Receives: Dietary Supplement: nutraceutical |
| Comparator Membraflex 300mg | Experimental | experimental product two doses Receives: Dietary Supplement: nutraceutical |
| Placebo Comparator | Placebo comparator | placebo product Receives: Dietary Supplement: nutraceutical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain from baseline at 8 weeks
analog visual scale
Measured: The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption).
Secondary outcomes (3)
quality of life test
The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain on a scale of: nothing, little, enough, a lot, and a lot) when performing activities in daily life.
Measured: it will be measured twice, once at baseline or at the end of the study after 8 weeks of use
functional test
The balance and mobility of the subjects will be measured with the Timed Up and Go Test
Measured: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
blood pressure
the arterial pressure will be measured to the subjects
Measured: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start20 Mar 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525249
- Sponsor's protocol ID
- UCAM-CFE-0002
- Acronym
- FISMEH
- Status last verified
- Oct 2019
- First submitted
- 9 Mar 2018
- Last updated
- 18 Oct 2019
- 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 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From the Internal Membrane of the Egg Shell on the Articular Pain of Diagnosed Patients of Arthrosis
- ClinicalTrials.gov ID
- NCT03525249
- Acronym / sponsor ID
- FISMEH / UCAM-CFE-0002
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 May 2018 (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.
Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the efficacy of a supplement extracted from the internal membrane of the egg shell on the joint pain of patients diagnosed with osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comparator Membraflex 500mg | Experimental | Dietary Supplement: nutraceuticalexperimental product one dose |
| Comparator Membraflex 300mg | Experimental | Dietary Supplement: nutraceuticalexperimental product two doses |
| Placebo Comparator | Placebo comparator | Dietary Supplement: nutraceuticalplacebo product |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years.
- Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
- Subjects must have persistent knee pain associated with osteoarthritis with an initial score of at least 30 mm in the assessment of pain according to the EVA scale.
- The subjects should not present in their treatment narcotic drugs or steroidal anti-inflammatory or immunosuppressive drugs.
Key exclusion criteria (7 listed)
- Serious or terminal illnesses.
- Subjects who are currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrates or any supplement indicated for joint health.
- Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
- Subjects with a body mass index above 32.
- Subjects with a known allergy to eggs.
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 |
|---|---|---|
| nutraceuticalSubjects will consume a capsule for eight weeks | Dietary supplement | Comparator Membraflex 300mg, Comparator Membraflex 500mg, Placebo Comparator |
Primary outcome
Change in Pain from baseline at 8 weeks
Time frame: The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption).
analog visual scale
3 secondary outcomes
quality of life test
Time frame: it will be measured twice, once at baseline or at the end of the study after 8 weeks of use
functional test
Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
blood pressure
Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
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 18 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutraceutical in people with Osteoarthritis, run by Universidad Católica San Antonio de Murcia 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 4 inclusion and 7 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 18 Oct 2019. 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.
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?
Change in Pain from baseline at 8 weeks (time frame: The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption).). 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 18 Oct 2019.