Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.
Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience
1 other identifier
observational
239
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 11, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedApril 12, 2023
November 1, 2022
2 years
October 11, 2021
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain using a Numerical Rating Scale (NRS)
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
Interventions
2 tablets in the morning and in the evening for minimum 6 weeks.
Eligibility Criteria
adults above 45 years with chronic hand joint discomfort
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tilman S.A.lead
Study Sites (2)
Yves Henrotin
Boncelles, Liège, 4100, Belgium
Yves Henrotin
Boncelles, 4100, Belgium
Study Officials
- STUDY DIRECTOR
Yvan Dierckxsens
Tilman S.A.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2021
First Posted
October 22, 2021
Study Start
September 1, 2019
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
April 12, 2023
Record last verified: 2022-11