Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.

Completed

• Conditions: Hand Joint Discomfort

• Registration Number: NCT05089318
• Lead Sponsor: Tilman S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Status Verified: 2022-11
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain using a Numerical Rating Scale (NRS)	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)

Trial Locations

Locations (1)

Yves Henrotin; 🇧🇪 Boncelles, Belgium