Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.

Completed

• Conditions: Gonarthrosis

• Registration Number: NCT02977936
• Lead Sponsor: PiLeJe

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).

Study Timeline

• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-30
• Study Start: 2017-03-12
• Primary Completion: 2019-05-14
• Study Completion: 2019-09-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients reaching the acceptability threshold of their state	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).

Secondary Outcome Measures

Name	Time	Method
OASIS Score	Day 90
Yes answer for the PASS	Day 90

Trial Locations

Locations (1)

Pileje Network of medical practitioners in private offices; 🇫🇷 Paris, France