Clinical trial NCT02977936: Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonarthrosis
Lead sponsor: PiLeJe
Sponsor class: INDUSTRY
First posted: 2016-11-30
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from gonarthrosic pain

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Percentage of patients reaching the acceptability threshold of their state
timeFrame: day 30
Secondary outcomes:
measure: OASIS Score
timeFrame: Day 30
measure: OASIS Score
timeFrame: Day 60
measure: OASIS Score
timeFrame: Day 90
measure: Yes answer for the PASS
timeFrame: Day 60
measure: Yes answer for the PASS
timeFrame: Day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Pileje Network of medical practitioners in private offices
Study officials:
References: