Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02977936|
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment|
|Gonarthrosis||Dietary Supplement: Cartimotil Fort|
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|
|Estimated Enrollment :||126 participants|
|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|
- Dietary Supplement: Cartimotil Fort
1 to 4 capsules per day during 90 days
- 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).
- OASIS Score [ Time Frame: Day 30 ]
- OASIS Score [ Time Frame: Day 60 ]
- OASIS Score [ Time Frame: Day 90 ]
- Yes answer for the PASS [ Time Frame: Day 60 ]
- Yes answer for the PASS [ Time Frame: Day 90 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977936
|Contact: Samira AIT ABDELLAH||+33(0)firstname.lastname@example.org|
|Contact: Caroline GAL||+33(0)email@example.com|
|Pileje Network of medical practitioners in private offices||Recruiting|