GonarthrosisNCT02977936
Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.
An observational study of Gonarthrosis, run by PiLeJe at 1 site in France.
Trial summary
The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- Cartimotil Fort
- Type of treatment
- Pill or oral medicine
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2017to 5 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from gonarthrosic pain
Who may be able to join
- VAS of pain : minimum 5/10 on walking or 4/10 at rest
- Patients with a negative PASS (patient considering that the symptomatic state is not acceptable)
- Suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful seizures (confirmed by a radio of less than two years: stage 2 or 3 on the Kellgreen scale - clinical examination)
- Having agreed to participate in the investigation after receiving information from the investigator
Who cannot join
- Patients with rheumatological disorders other than osteoarthritis
- Patients for whom knee surgery is planned within 3 months
- Patients who started treatment with chondroitin sulphate (or all treatments of osteoarthritis other than anti-inflammatories and analgesics) for less than one month
- Patients with a BMI greater than 35
- Patients with chronic pain that can interfere with knee osteoarthritis pain
- Patients with reduced mobility or bedridden
Show all 10Show fewer
- Patients with cognitive impairments not able to participate in the study
- Patients with known allergies to any of the ingredients of Cartimotil Fort®
- Pregnant or breastfeeding patients
- Patients who do not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study for the Management of Joint Pain Associated With Osteoarthritis of the Knee: Association of Extracts of Curcuma Longa, Boswellia Serrata and Porphyra Umbilicalis.
The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.
Read the detailed description
For this study, 126 patients are going to be included. They will have a supplementation of Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.
on the one hand, during the two visits (inclusion and follow-up), the investigator completes the questionnaire about neuropathic pain (DN4).
on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4 times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6 times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just before the follow-up visit (day 90).
- Conditions
- Gonarthrosis
- Being tested
- Cartimotil Fort
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartimotil FortDietary supplement
1 to 4 capsules per day during 90 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients reaching the acceptability threshold of their state
Percentage of patients reaching the acceptability threshold of their state between D0 and D30 measured by the binary response of the PASS (yes = acceptable).
Measured: day 30
Secondary outcomes (5)
OASIS Score
Measured: Day 30
OASIS Score
Measured: Day 60
OASIS Score
Measured: Day 90
Yes answer for the PASS
Measured: Day 60
Yes answer for the PASS
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start12 Mar 2017
- Primary completion14 May 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GonarthrosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977936
- Sponsor's protocol ID
- PiL-Obs-CFort-016
- Status last verified
- Sep 2020
- First submitted
- 25 Nov 2016
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Perrot S, Trouvin AP, Bouhassira D. Three dimensions of pain in osteoarthritis: development and validation of the Osteoarthritis Symptom Inventory Scale. Pain. 2023 Jul 1;164(7):1566-1577. doi: 10.1097/j.pain.0000000000002856. Epub 2023 Mar 22.
PubMed 36602324
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study for the Management of Joint Pain Associated With Osteoarthritis of the Knee: Association of Extracts of Curcuma Longa, Boswellia Serrata and Porphyra Umbilicalis.
- ClinicalTrials.gov ID
- NCT02977936
- Acronym / sponsor ID
- PiL-Obs-CFort-016
- Conditions
- Gonarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 30 Nov 2016 (estimated)
- 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 the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.
Detailed description
For this study, 126 patients are going to be included. They will have a supplementation of Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.
on the one hand, during the two visits (inclusion and follow-up), the investigator completes the questionnaire about neuropathic pain (DN4).
on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4 times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6 times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just before the follow-up visit (day 90).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from gonarthrosic pain
Key inclusion criteria (4 listed)
- VAS of pain : minimum 5/10 on walking or 4/10 at rest
- Patients with a negative PASS (patient considering that the symptomatic state is not acceptable)
- Suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful seizures (confirmed by a radio of less than two years: stage 2 or 3 on the Kellgreen scale - clinical examination)
- Having agreed to participate in the investigation after receiving information from the investigator
Key exclusion criteria (10 listed)
- Patients with rheumatological disorders other than osteoarthritis
- Patients for whom knee surgery is planned within 3 months
- Patients who started treatment with chondroitin sulphate (or all treatments of osteoarthritis other than anti-inflammatories and analgesics) for less than one month
- Patients with a BMI greater than 35
- Patients with chronic pain that can interfere with knee osteoarthritis pain
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 |
|---|---|---|
| Cartimotil Fort1 to 4 capsules per day during 90 days | Dietary supplement | – |
Primary outcome
Percentage of patients reaching the acceptability threshold of their state
Time frame: day 30
Percentage of patients reaching the acceptability threshold of their state between D0 and D30 measured by the binary response of the PASS (yes = acceptable).
5 secondary outcomes
OASIS Score
Time frame: Day 30
OASIS Score
Time frame: Day 60
OASIS Score
Time frame: Day 90
Yes answer for the PASS
Time frame: Day 60
Yes answer for the PASS
Time frame: Day 90
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 29 Sep 2020.
- Derived from this study: PubMed 36602324Perrot S, Trouvin AP, Bouhassira D. Three dimensions of pain in osteoarthritis: development and validation of the Osteoarthritis Symptom Inventory Scale. Pain. 2023 Jul 1;164(7):1566-1577. doi: 10.1097/j.pain.0000000000002856. Epub 2023 Mar 22.
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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.
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?
An observational study of Gonarthrosis, run by PiLeJe at 1 site in France.
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 10 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 29 Sep 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 France. 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?
Percentage of patients reaching the acceptability threshold of their state (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02977936, which also lists 1 linked publication.
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 29 Sep 2020.