NCT05089318CompletedNot Applicable
Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience
Tilman S.A.1 site in 1 country239 target enrollmentStarted: September 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 239
- Locations
- 1
- Primary Endpoint
- Pain using a Numerical Rating Scale (NRS)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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