Functional Improvement and Safety of a Multicomponent Formulation Containing Undenatured UC-II® Collagen, Magnesium, Boswellia Serrata, and Turmeric in Patients with Joint Disorders (FISMFJD)

Study summary

Study identification

• EU PAS number:
  EUPAS1000001035
• Study ID:
  1000001035
• Official title and acronym:
  Functional Improvement and Safety of a Multicomponent Formulation Containing Undenatured UC-II® Collagen, Magnesium, Boswellia Serrata, and Turmeric in Patients with Joint Disorders (FISMFJD)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Objective: To evaluate the clinical efficacy, safety, and longitudinal functional response of a multicomponent dietary supplement (Artiok®) in patients with musculoskeletal pathology under routine, real-world clinical conditions.; Methods:This was a prospective, multicentre, observational real-world evidence study. A single initial cohort of 289 patients with chronic joint pain and functional limitation was enrolled. Outcomes were assessed at baseline (V1) and 30 days (V2) for the full cohort (n=289), and at 90 days (V3) for the patients who completed the full longitudinal protocol (n=190). Outcomes were quantified using a validated 24-item WOMAC-based questionnaire converted to a 0–4 Likert scale. Statistical analysis was performed using non-parametric paired Wilcoxon Signed-Rank tests and Mann-Whitney U tests for independent cohorts.; Results:For the longitudinal completers (n=190), continuous supplementation yielded a 48.54% reduction in the Total WOMAC score and a 51.11% reduction in global pain at 90 days (p < 0.001). Significant biomechanical restoration was observed; functional difficulty getting in and out of a vehicle decreased by 52.86%, while pain descending stairs improved by 47.24% (p < 0.001). The formulation also attenuated resting inflammation, reducing nocturnal pain by 48.80% and morning stiffness by 46.90%. Notably, a secondary analysis revealed that patients managing pain exclusively with the supplement achieved a 52.36% pain reduction, statistically comparable to those requiring concomitant NSAIDs or rescue analgesics (47.34%, p = 0.285). Regarding safety, zero adverse events (0%) were reported across the entire enrolled cohort of 289 patients.; Conclusion:Supplementation with the multicomponent Artiok® formulation is associated with clinically and statistically significant improvements in pain and functional autonomy in a real-world setting.The synergistic mechanism offers rapid symptomatic relief, making it a viable strategy for joint management.
• Study status:
  Finalised

Research institutions and networks

Institutions

BIOKSAN

Spain

Study timelines

Date when funding contract was signed

Planned:17/01/2022

Actual:25/01/2022

Study start date

Planned:02/02/2022

Actual:02/02/2022

Date of final study report

Planned:08/06/2026

Actual:08/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bioksan Naturalmente Juntos SL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable