Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 6:12 PM
Study NCT ID:
NCT05570123
Status:
None
Last Update Posted:
2025-04-08 00:00:00
First Post:
2022-10-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect and Tolerance of Standardized Exclusive Dry Extracts of Curcuma Longa and of Boswellia Serrata Among People With Hand Joint Discomfort and Dysfunction
Sponsor:
None
Organization:
Study Overview
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.
Status:
None
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLEXOA
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: