Hand Joint DiscomfortFLEXOANCT05570123

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

A study testing Flexofytol Forte in people with Hand Joint Discomfort and Hand Joint Dysfunction, run by Tilman S.A. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Hand Joint Discomfort, Hand Joint Dysfunction
What is being tested?: Flexofytol Forte
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteBelgium
Study dates: 14 Sep 2022to 23 Jan 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

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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

Who cannot join

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).

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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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UZ Gent (national coordinating site)
Ghent

Other trials in Belgium

About this study

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 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.

Read the detailed 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.

Conditions: Hand Joint Discomfort, Hand Joint Dysfunction
Being tested: Flexofytol Forte, Placebo
Keywords: Hand joint pain, Curcuma, Boswellia, Flexofytol Forte

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05570123
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Dietary Supplement: Placebo
Flexofytol Forte	Experimental	Not described Receives: Dietary Supplement: Flexofytol Forte

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
0 -100 mm Visual Analog Scale (VAS)-From 0 (No pain) to 100 (maximal pain)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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%
Measured: 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
Measured: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of tender and /or swollen joints counts
Measured: 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
Measured: 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
Measured: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of consumption of paracetamol and oral NSAIDS
recording via a diary
Measured: 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)
Measured: 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)
Measured: 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%
Measured: 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
Measured: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of tender and /or swollen joints counts
Measured: 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
Measured: 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
Measured: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of consumption of paracetamol and oral NSAIDS
recording via a diary
Measured: 3 months (between V0 and V3 visits)
Tolerance
Record of adverse and Serious Adverse Events (AE; SAE) and drop-outs
Measured: 3 months (between V0 and V3 visits)
Compliance
Tablet count by the investigator
Measured: 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
Measured: 3 months (between V0 and V3 visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202223 Jan 2024

First posted6 Oct 2022
Study start14 Sep 2022
Primary completion23 Jan 2024
Study completion23 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hand Joint DiscomfortStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05570123
Sponsor's protocol ID: FLEXOA
Acronym: FLEXOA
Status last verified: Jan 2024
First submitted: 5 Oct 2022
Last updated: 8 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05570123
Acronym / sponsor ID: FLEXOA / FLEXOA
Conditions: Hand Joint Discomfort, Hand Joint Dysfunction
Keywords: Hand joint pain, Curcuma, Boswellia, Flexofytol Forte
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Tilman S.A.Industry (pharma, biotech, devices)
Collaborators: Artialis
Study start: 14 Sep 2022 (actual)
Primary completion: 23 Jan 2024 (actual)
Study completion: 23 Jan 2024 (actual)
First posted: 6 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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).

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: Placebo
Flexofytol Forte	Experimental	Dietary Supplement: Flexofytol Forte

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Body Mass Index ≤ 35 kg/m2
Subjects that fulfil the following American College of Rheumatology (ACR) clinical criteria :
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.

Key exclusion criteria (30 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flexofytol Fortestandardized exclusive dry extracts of Curcuma longa and Boswellia serrata. 2 tablets a day, one in the morning, one in the evening	Dietary supplement	Flexofytol Forte
Placebo2 tablets a day, one in the morning, one in the evening	Dietary supplement	Placebo

Primary outcome

Changes from baseline to 3 months of mean finger pain during the last 24 hours
Time frame: 3 months (between V0 and V2 visits)
0 -100 mm Visual Analog Scale (VAS)-From 0 (No pain) to 100 (maximal pain)

21 secondary outcomes

Changes from baseline to 1 month of Mean finger pain evaluated in both hands during the last 24 hours
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
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of functional disability
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of PGA
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of Minimum Clinically Important improvement (MCHII)
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of Participant Acceptable important Symptom State (PASS)
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
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of quality of life
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 1 month of consumption of paracetamol and oral NSAIDS
Time frame: 1 month (between V0 and V1 visits)
Changes from baseline to 3 months of functional disability
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of PGA
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of Minimum Clinically Important improvement (MCHII)
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of Participant Acceptable important Symptom State
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
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of quality of life
Time frame: 3 months (between V0 and V3 visits)
Changes from baseline to 3 months of consumption of paracetamol and oral NSAIDS
Time frame: 3 months (between V0 and V3 visits)
Tolerance
Time frame: 3 months (between V0 and V3 visits)
Compliance
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruth Wittoek (National coordinator), Pr, MD principal investigator

UZ Gent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flexofytol Forte in people with Hand Joint Discomfort and Hand Joint Dysfunction, run by Tilman S.A. at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline to 3 months of mean finger pain during the last 24 hours (time frame: 3 months (between V0 and V2 visits)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05570123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.