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OpenTrials
Completed

NCT Number: NCT02977936

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pileje Network of medical practitioners in private offices

Paris, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cartimotil Fort

Dietary Supplement

1 to 4 capsules per day during 90 days

Primary outcomes

  1. 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).

Secondary outcomes

  1. OASIS Score

    Time frame: Day 30

  2. OASIS Score

    Time frame: Day 60

  3. OASIS Score

    Time frame: Day 90

  4. Yes answer for the PASS

    Time frame: Day 60

  5. Yes answer for the PASS

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2016
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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