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

Gonarthrosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977936
• Other study ID #: PiL-Obs-CFort-016
• Status: Completed
• Start date: March 12, 2017
• Est. completion date: September 5, 2019

Study information

• Verified date: September 2020
• Source: Pileje
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 5, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthralgia
• Gonarthrosis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Cartimotil Fort
1 to 4 capsules per day during 90 days

Locations

Country	Name	City	State
France	Pileje Network of medical practitioners in private offices	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pileje

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OASIS Score		Day 30
Secondary	OASIS Score		Day 60
Secondary	OASIS Score		Day 90
Secondary	Yes answer for the PASS		Day 60
Secondary	Yes answer for the PASS		Day 90