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

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ClinicalTrials.gov Identifier: NCT02977936
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gonarthrosis Dietary Supplement: Cartimotil Fort

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).


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Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : March 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis


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


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from gonarthrosic pain
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977936


Contacts
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Contact: Samira AIT ABDELLAH +33(0)145517877 s.aitabdellah@pileje.com
Contact: Caroline GAL +33(0)145517877 c.gal@pileje.com

Locations
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France
Pileje Network of medical practitioners in private offices Recruiting
Paris, France
Sponsors and Collaborators
Pileje

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Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT02977936     History of Changes
Other Study ID Numbers: PiL-Obs-CFort-016
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthralgia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms