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

Tilman S.A.

Status

Completed

Conditions

Hand Joint Dysfunction

Hand Joint Discomfort

Treatments

Dietary Supplement: Flexofytol Forte

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05570123

FLEXOA

Details and patient eligibility

About

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.

Full description

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.

Enrollment

180 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body Mass Index ≤ 35 kg/m2
Subjects that fulfil the following American College of Rheumatology (ACR) clinical criteria :
- Hand pain, aching, or stiffness AND
- 3 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.

Pain in hands at least half of the days in the previous month and for at least 48 h prior to the inclusion/baseline visit.
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

Exclusion criteria

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

Analgesics and anti-inflammatory medications (oral and topic) other than Paracetamol and oral NSAIDS at inclusion except if a wash-out period is respected.
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
Anticipated need for any joint discomfort including OA treatments forbidden during the study
Hand surgery or fracture within the last 6 months, or hand surgery planned within the next 3 months
Physiotherapy for hand pain and dysfunction in the past month.

Related to associated diseases

Severe and uncontrolled diseases (such as peptic ulcer, renal impairment, hepatic dysfunction, hematologic disease, cancer within 5 years (except treated Basal Cell Carcinoma, BCC), HIV, etc.)
Participants who cannot swallow tablets because of the size of the tablets that cannot be cut or disintegrated.
Any other significant or uncontrolled disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study (as disease with widespread pain)

Related to subjects

Close collaborators to the investigational team, the study coordinator (ARTIALIS) or the Sponsor (TILMAN)
Having participated or currently participating to a clinical trial in the last 3 months
Vegan people (the product contains bovine gelatin)
Under guardianship or judicial protection
Pregnancy, breastfeeding, planned conception
Women of childbearing age without contraception