Hand Joint DiscomfortNCT05089318
Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.
An observational study of Hand Joint Discomfort, run by Tilman S.A. at 2 sites in Belgium.
Trial summary
The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hand Joint Discomfort
- What is being tested?
- Flexofytol PLUS
- Type of treatment
- Pill or oral medicine
- How many people
- 239 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2019to 1 Sep 2021
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults above 45 years with chronic hand joint discomfort
Who may be able to join
- Older dan 45 years old,
- With hand joint chronic discomfort,
- Regularly uses of paracetamol or NSAIDs to manage pain,
- Painful symptoms must have been present for more than 6 months,
- The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours.
Who cannot join
- Related to previous and associated treatments:
- Corticosteroids injection in the 3 previous months, whatever the joint concerned,
- Use of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy or homeopathy for hand joint discomfort..),
- Anticoagulant (coumarinic) treatment and heparin,
- General corticotherapy in the 3 previous months,
- Contraindication to paracetamol, curcumin, boswellia and NSAID's.
Show all 12Show fewer
- Related to associated pathologies:
- Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
- The patient has rheumatoid arthritis or gout,
- The patient has a bile obstruction.
- Related to patient:
- Pregnant or breastfeeding women.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Yves Henrotin
Boncelles, Liège, 4100
Yves Henrotin
Boncelles, 4100
About this study
Official title: Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience
The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.
- Conditions
- Hand Joint Discomfort
- Being tested
- Flexofytol PLUS
- Keywords
- Hand joint pain, curcumin, boswellia serrata, support to standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexofytol PLUSDietary supplement
2 tablets in the morning and in the evening for minimum 6 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using a Numerical Rating Scale (NRS)
Change from baseline of the mean pain over the last 48 hours evaluated by the patient on a 0 to 10 scale ( 0= no pain and 10=maximal pain)
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Sep 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Joint DiscomfortStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Tilman S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvan Dierckxsens, Study director, Tilman S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089318
- Sponsor's protocol ID
- FLEXOPAM
- Status last verified
- Nov 2022
- First submitted
- 11 Oct 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience
- ClinicalTrials.gov ID
- NCT05089318
- Acronym / sponsor ID
- FLEXOPAM
- Conditions
- Hand Joint Discomfort
- Keywords
- Hand joint pain, curcumin, boswellia serrata, support to standard treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Tilman S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Oct 2021 (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 purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults above 45 years with chronic hand joint discomfort
Key inclusion criteria (5 listed)
- Older dan 45 years old,
- With hand joint chronic discomfort,
- Regularly uses of paracetamol or NSAIDs to manage pain,
- Painful symptoms must have been present for more than 6 months,
- The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours.
Key exclusion criteria (12 listed)
- Related to previous and associated treatments:
- Related to associated pathologies:
- Related to patient:
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 |
|---|---|---|
| Flexofytol PLUS2 tablets in the morning and in the evening for minimum 6 weeks. | Dietary supplement | – |
Primary outcome
Pain using a Numerical Rating Scale (NRS)
Time frame: 84 days
Change from baseline of the mean pain over the last 48 hours evaluated by the patient on a 0 to 10 scale ( 0= no pain and 10=maximal pain)
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 12 Apr 2023.
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.
Yvan Dierckxsens study director
Tilman S.A.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Joint Discomfort, run by Tilman S.A. at 2 sites in Belgium.
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 5 inclusion and 12 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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. 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?
Pain using a Numerical Rating Scale (NRS) (time frame: 84 days). 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 12 Apr 2023.