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

September 28, 2020 updated by: PiLeJe

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Pileje Network of medical practitioners in private offices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from gonarthrosic pain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
OASIS Score
Time Frame: Day 30
Day 30
OASIS Score
Time Frame: Day 60
Day 60
OASIS Score
Time Frame: Day 90
Day 90
Yes answer for the PASS
Time Frame: Day 60
Day 60
Yes answer for the PASS
Time Frame: Day 90
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PiLeJe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2017

Primary Completion (Actual)

May 14, 2019

Study Completion (Actual)

September 5, 2019

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

November 25, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PiL-Obs-CFort-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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