Hand Joint Discomfort Clinical Trial
Official title:
Effect and Tolerance of Standardized Exclusive Dry Extracts of Curcuma Longa (CURTIL03) and of Boswellia Serrata (BOSTIL01) in Support of Standard Treatments Among People With Hand Joint Discomfort and Dysfunction: a Multicenter Hospital Setting, Randomized, Blinded, Placebo-controlled Clinical Study.
The objective of the study is to evaluate the effect and tolerance of standardized exclusive dry extracts of Curcuma longa (CURTIL03) and of Boswellia serrata (BOSTIL01) among people with hand joint discomfort and dysfunction. The study is prospective, randomized, double-blinded, placebo-controlled with 2 parallel-groups in 200 participants. The study is multicentric and will be done by 11 investigators located in Belgium including rheumatologists, sports and rehabilitation physicians, physical therapists, or any hand articular disease specialists.
200 adult subjects suffering from significant hand joint discomfort will be randomized per site in 2 parallel groups (100 subjects per group). Each patient will be enrolled in the study for 3 months including 3 visits: Inclusion/Baseline visit (V0), follow-up visits after 1 month (V1) and 3 months (V2). A-PRIMARY OBJECTIVE Evaluate the effect of the association of standardized exclusive dry extracts of Curcuma longa CURTIL03 and Boswellia serrata BOSTIL01 versus placebo on the fingers pain after 3 months supplementation. B-SECONDARY OBJECTIVES Evaluate: - finger pain on both hands at 1 month (mean and AUC) and 3 months (AUC) - Functional disability at any timepoint (self-administrate questionnaire) - Participant Global Assessment (PGA) at any timepoint - To evaluate Minimum Clinically Important Improvement (MCII) - To calculate Participant Acceptable important Symptom State (PASS) - Consumption of rescue treatment (Paracetamol and oral NSAIDS) for hand pain at any timepoint - Tender and swollen joints at any timepoint - Grip strength at any timepoint - Quality of life (e.g. including mood, sleep, disability) at any timepoint - Tolerance to the product at 1 and 3 months - Compliance to the product at 1 and 3 months - Responder to supplementation at 1 and 3 months EXPLORATIVE OBJECTIVES • Evaluate the blood level of cartilage catabolism and inflammatory biomarkers before and after 3 months of supplementation. ;