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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
180
standardized exclusive dry extracts of Curcuma longa and Boswellia serrata. 2 tablets a day, one in the morning, one in the evening
2 tablets a day, one in the morning, one in the evening
UZ Gent (national coordinating site)
Ghent, Belgium
Changes from baseline to 3 months of mean finger pain during the last 24 hours
0 -100 mm Visual Analog Scale (VAS)-From 0 (No pain) to 100 (maximal pain)
Time frame: 3 months (between V0 and V2 visits)
Changes from baseline to 1 month of Mean finger pain evaluated in both hands during the last 24 hours
0 -100 mm Visual Analog Scale (VAS)-From 0 (No pain) to 100 (maximal pain)
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of AUC finger pain intensity evaluated in both hands during the last 24 hours
0 -100 mm Visual Analog Scale (VAS)-From 0 (No pain) to 100 (maximal pain)
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of functional disability
Functional Index For Hand Osteoarthritis (FIHOA) self-reported questionnaire-from 0 (no functional impairment) to 30 points (maximal impairment)
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of PGA
0 -100 mm Visual Analog Scale (VAS)-From 0 (No impact) to 100 (maximal impact)
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of Minimum Clinically Important improvement (MCHII)
Calculated on Visual Analog Scale (finger pain)-absolute change of 15 mm or relative change of 20%
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of Participant Acceptable important Symptom State (PASS)
Calculated on Visual Analog Scale (finger pain)- \< 40 mm
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of tender and /or swollen joints counts
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of Grip strength of both hands
measured by dynamometer-0 to 90 Kilograms-increased strength defines an improvement in hand function
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of quality of life
using Short Form (SF)-36 questionnaire-0 to 100 range-high score defines a more favorable health state
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of consumption of paracetamol and oral NSAIDS
recording via a diary
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 3 months of functional disability
FIHOA self-reported questionnaire-from 0 (no functional impairment) to 30 points (maximal impairment)
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of PGA
0 -100 mm Visual Analog Scale (VAS)-From 0 (No impact) to 100 (maximal impact)
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of Minimum Clinically Important improvement (MCHII)
Calculated on Visual Analog Scale (finger pain)-absolute change of 15 mm or relative change of 20%
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of Participant Acceptable important Symptom State
Calculated on Visual Analog Scale (finger pain)- \< 40 mm
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of tender and /or swollen joints counts
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of Grip strength of both hands
measured by dynamometer-0 to 90 Kilograms-increased strength defines an improvement in hand function
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of quality of life
using SF-36 questionnaire-0 to 100 range-high score defines a more favorable health state
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of consumption of paracetamol and oral NSAIDS
recording via a diary
Time frame: 3 months (between V0 and V3 visits)
Tolerance
Record of adverse and Serious Adverse Events (AE; SAE) and drop-outs
Time frame: 3 months (between V0 and V3 visits)
Compliance
Tablet count by the investigator
Time frame: 3 months (between V0 and V3 visits)
Fulfillment of Osteoarthritis Research Society International (OARSI) responder criteria from OMERACT(Outcome Measures in Rheumatoid Arthritis Clinical Trials)-OARSI initiative
Time frame: 3 months (between V0 and V3 visits)
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