Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.

April 11, 2023 updated by: Tilman S.A.

Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience

The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

239

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

  • Belgium
      • Boncelles, Belgium, 4100
        • Yves Henrotin
    • Liège
      • Boncelles, Liège, Belgium, 4100
        • Yves Henrotin

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adults above 45 years with chronic hand joint discomfort

Description

Inclusion Criteria:

  • Older dan 45 years old,
  • With hand joint chronic discomfort,
  • Regularly uses of paracetamol or NSAIDs to manage pain,
  • Painful symptoms must have been present for more than 6 months,
  • The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours.

Exclusion Criteria:

  • Related to previous and associated treatments:

    • Corticosteroids injection in the 3 previous months, whatever the joint concerned,
    • Use of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy or homeopathy for hand joint discomfort..),
    • Anticoagulant (coumarinic) treatment and heparin,
    • General corticotherapy in the 3 previous months,
    • Contraindication to paracetamol, curcumin, boswellia and NSAID's.

  • Related to associated pathologies:

    • Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
    • The patient has rheumatoid arthritis or gout,
    • The patient has a bile obstruction.

  • Related to patient:

    • Pregnant or breastfeeding women.

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain using a Numerical Rating Scale (NRS)
Time Frame: 84 days
Change from baseline of the mean pain over the last 48 hours evaluated by the patient on a 0 to 10 scale ( 0= no pain and 10=maximal pain)
84 days

Collaborators and Investigators

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

Sponsor

Tilman S.A.

Investigators

  • Study Director: Yvan Dierckxsens, Tilman S.A.

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)

September 1, 2019

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FLEXOPAM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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