Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.

Tilman S.A.

Status: Completed

Conditions: Hand Joint Discomfort

Treatments: Dietary Supplement: Flexofytol PLUS

Study type: Observational

Funder types: Industry

Identifiers

NCT05089318

FLEXOPAM

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.