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OpenTrials
Completed

NCT Number: NCT05089318

Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yves Henrotin, Boncelles, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flexofytol PLUS

Dietary Supplement

2 tablets in the morning and in the evening for minimum 6 weeks.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Tilman S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2021
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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