Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Hand Joint Discomfort

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Flexofytol PLUS

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No