Effect and Tolerance of Standardized Exclusive Dry Extracts of Curcuma Longa and of Boswellia Serrata Among People With Hand Joint Discomfort and Dysfunction

NCT05570123 | Completed

• 1 other identifier: FLEXOA
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Joint Discomfort; Hand Joint Dysfunction

Keywords

Hand joint pain; Curcuma; Boswellia; Flexofytol Forte

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months (between V0 and V2 visits)

Secondary Outcomes (21)

• Changes from baseline to 1 month of Mean finger pain evaluated in both hands during the last 24 hours

  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

  1 month (between V0 and V1 visits)

• Changes from baseline to 1 month of functional disability

  1 month (between V0 and V1 visits)

• Changes from baseline to 1 month of PGA

  1 month (between V0 and V1 visits)

• Changes from baseline to 1 month of Minimum Clinically Important improvement (MCHII)

  1 month (between V0 and V1 visits)

Other Outcomes (1)

• Change from baseline to 3 months in blood levels of cartilage metabolism and inflammatory biomarkers

  3 months (between V0 and V3 visits)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Flexofytol Forte

EXPERIMENTAL

Dietary Supplement: Flexofytol Forte

Interventions

Flexofytol Forte DIETARY_SUPPLEMENT

standardized exclusive dry extracts of Curcuma longa and Boswellia serrata. 2 tablets a day, one in the morning, one in the evening

Flexofytol Forte

Placebo DIETARY_SUPPLEMENT

2 tablets a day, one in the morning, one in the evening

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index ≤ 35 kg/m2
• Subjects that fulfil the following American College of Rheumatology (ACR) clinical criteria :
• Hand pain, aching, or stiffness AND
• or 4 of the following features:
• Hard tissue enlargement of 2 or more of 10 selected joints,
• Hard tissue enlargement of 2 or more Distal interphalangeal (DIP) joints,
• Fewer than three swollen metacarpophalangeal (MCP) joints,
• Deformity of at least 1 of 10 selected hand joints.
• The 10 selected joints are the second and third Distal Interphalangeal joint (DIP), the second and third Proximal Interphalangeal joints (PIP), and the first carpometacarpal (CMC) joints of both hands.
• Finger pain score of 40-80 mm on a 100 mm Visual Analog Scale (VAS) on at least one hand over the last 24 hours. Subjects should respect a 24-hours wash-out period of authorized analgesic/anti-inflammatory medications (Paracetamol/oral NSAIDs) before the visit.
• Willing to use only Paracetamol and oral NSAIDS as rescue treatment to manage hand pain during the study. Others analgesics and anti-inflammatory medication (oral and topic) are not allowed during the study and a wash out period of 5 half-life depending of the molecule should be respected before study entry.
• Able to follow the instructions of the study
• Having signed an informed consent

You may not qualify if:

• Subjects that meet AT LEAST one of the following criteria will be excluded:
• Related to hand
• Subjects with discomfort uniquely of thumb joints.
• Other rheumatic diseases such gout, rheumatoid arthritis, psoriatic arthritis, to name a few) should be excluded.
• Concurrent articular diseases or hand/upper limb disorders interfering with the evaluation of hand pain such as but not limited to inflammatory arthritis, connective tissue disorder, chronic pain or alternative clinical diagnosis such as tenosynovitis or carpal tunnel syndrome, such as poly-articular chondrocalcinosis, thoracic outlet syndrome, carpal tunnel, Guyon's canal syndrome, cubital tunnel syndrome, diabetic neuropathy or cheiroarthropathy, palmar tenosynovitis, trigger finger, fibromyalgia, pain syndrome (Complex Regional Pain Syndrome or algoneurodystrophy) diagnosed within past 6 months (left to Principal Investigator (PI) discretion).
• Major injury in hand joint(s) and tendons within past 6 months (left to PI discretion).
• Related to treatments
• Intra-articular corticosteroids in past 3 months in any joint.
• Intra-articular Hyaluronic Acid in any hand/finger joint within past 6 months.
• Intra-articular platelet-rich plasma in any hand/finger joint within past 6 months.
• Use of Slow-acting drugs for OA (SYSADOA) and/or dietary supplements in the last 3 months (e.g. chondroitin sulfate, diacerein, soy and avocado unsaponifiables, collagen, hyaluronic acid, oxaceprol, copper granions, glucosamine, phytotherapy for joints pain and dysfunction, homeopathy for joints pain and dysfunction, dietary supplements based on curcumin and/or Boswellic acids)
• Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months
• Allergy or contra-indication to the studied product or any ingredient present in this product or in placebo. Attention to medication interaction, see section on prohibited treatments
• Intolerance to Paracetamol and NSAIDS (rescue treatments during the study)
• Anticoagulant (coumarin compound) and heparin. New generation anticoagulants are authorized

Sponsors & Collaborators

• Tilman S.A.: lead
• Artialis: collaborator

Study Sites (1)

UZ Gent (national coordinating site)

Ghent, Belgium

Location

Study Officials

• Ruth Wittoek (National coordinator), Pr, MD

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 6, 2022
• Study Start: September 14, 2022
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: April 8, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)