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

NCT02977936 | Completed

• 1 other identifier: PiL-Obs-CFort-016
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonarthrosis

Outcome Measures

Primary Outcomes (1)

• 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).

  day 30

Secondary Outcomes (5)

• OASIS Score

  Day 30

• OASIS Score

  Day 60

• OASIS Score

  Day 90

• Yes answer for the PASS

  Day 60

• Yes answer for the PASS

  Day 90

Interventions

Cartimotil Fort DIETARY_SUPPLEMENT

1 to 4 capsules per day during 90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from gonarthrosic pain

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PiLeJe: lead

Study Sites (1)

Pileje Network of medical practitioners in private offices

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 36602324 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: November 30, 2016
• Study Start: March 12, 2017
• Primary Completion: May 14, 2019
• Study Completion: September 5, 2019
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

FR (1)