Knee DiscomfortT-MOTIONNCT04506411
Turmeric Efficacy for Mobility and Joint Function
A study testing Turmipure GOLD® and Turmeric rhizome PE 95% curcuminoids in people with Knee Discomfort and Joint Pain, run by Givaudan France Naturals at 8 sites in 2 countries.
Trial summary
The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD® supplementation to reduce joint discomfort. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Discomfort, Joint Pain
- What is being tested?
- Turmipure GOLD® and Turmeric rhizome PE 95% curcuminoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 24 Sep 2020to 3 Mar 2023
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consent to the study and to comply with study product
- Who have a BMI between 18 and 32 kg/m²
- Who has mild to moderate knee pain for at least 3 months before enrollment (VAS between 40 to 70 on 100mm scale after respecting a washout period depending on the half-life of the excluded medications)
- Who has radiographic evidence of Kellgren-Lawrence score 0, 1, 2 and 3 in the tibio-femoral compartment of the target knee
- Who is able to perform the physical performance-based tests and understands all questions from the WOMAC questionnaire
- Who is willing to refrain from taking any pain reliever (OTC or prescription) and other pharmacological, nutritional agent (e.g. glucosamine), device or therapy (e.g. acupuncture) which may influence the study outcome during the entire trial (other than determined authorized rescue medication)
- Who is willing to not change dietary habits, level of physical activity (including any heavy physical work with high loading of the knee joints) and body weight
Who cannot join
- Subjects with any clinically significant levels of the safety parameters at screening
- Pregnant or lactating females, or wishing to become pregnant during the study
- Subject with joint pain related to some predisposing conditions that have adversely altered the joint tissues often due to a specific cause
- Subject with Kellgren-Lawrence grade 4 in the tibio-femoral compartment of the target knee
- Who has clinically apparent tense effusion of the target knee or other joint
- Who has/had viscosupplementation in any joint including the target knee or other joint within 6 months prior to screening
Show all 20Show fewer
- Who has concomitant inflammatory disease or other condition that affects the joints deemed exclusionary by the Principal Investigator (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc…)
- Who has symptomatic osteoarthritis of the contralateral knee that is not responsive to paracetamol and requires other therapy
- Who is taking any treatment/supplementation which may interfere with study conduct and interpretation of study results (4-weeks washout, e.g. glucosamine, chondroitin, corticosteroids) except calcium and vitamin D supplements
- Who is under any medical condition deemed exclusionary by the Principal Investigator
- Subject has a history of drug and / or alcohol abuse at the time of enrollment
- Change of dietary habit within the preceding month
- Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumor of intestine or colon and significant systemic disease
- Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
- Subject with known allergy to components of the test product
- Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
- Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing)
- Who is taking any anticoagulant or heparin treatment
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Slovenia6 sites
Ortopedska bolnišnica Valdoltra
Ankaran
Splošna bolnišnica Jesenice, Oddelek za ortopedijo
Jesenice
Bisturmed, d.o.o., Ortopedija in fizioterapija
Koper
Poliklinika Nobilis, d.o.o., enota LJ, Ortopedska ambulanta
Ljubljana
Medicinsko termalni center Fontana, d.o.o., Ortopedska ambulanta
Maribor
Univerzitetni klinični center Maribor, Oddelek za ortopedijo
Maribor
About this study
Official title: Placebo Controlled Randomized Clinical Trial to Evaluate Efficacy of Turmipure Gold® to Improve Joint Function in Subjects With Distinct Kellgren-Lawrence Knee Radiographic Scores
The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD® supplementation to reduce joint discomfort.
Read the detailed description
The aim of this clinical study is to determine whether oral administration of Turmipure GOLD® can contribute to the improvement of mobility and joint function in adult population with knee discomfort and with distinct Kellgren-Lawrence (K\&L) knee radiographic scores.
- Conditions
- Knee Discomfort, Joint Pain
- Being tested
- Turmipure GOLD®, Turmeric rhizome PE 95% curcuminoids, Placebo
- Keywords
- Mobility, Joint function, Turmeric, Curcuminoids
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turmipure GOLD®Dietary supplement
TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed
Turmeric rhizome PE 95% curcuminoidsDietary supplement
STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed
PlaceboDietary supplement
Placebo: Maltodextrin - 4 capsules once daily- as prescribed
| Study group | Role | What they receive |
|---|---|---|
| TPG | Experimental | 59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 12 weeks Receives: Dietary Supplement: Turmipure GOLD® |
| STE | Active comparator | 59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive standard turmeric extract 95% curcuminoids (STE) product during 12 weeks Receives: Dietary Supplement: Turmeric rhizome PE 95% curcuminoids |
| Control | Placebo comparator | 59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (maltodextrin) product during 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC™ Pain
Knee joint pain discomfort assessed with the validated Western Ontario and McMaster University questionnaire (WOMAC) using its visual analogue scale version (VAS). The WOMAC VA 3.1 Pain subscore (WOMAC A) ranges from 0 to 100 mm (averaging five VAS 0-100 mm) with higher scores indicating more pain.
Measured: 12-weeks
Secondary outcomes (14)
Change in WOMAC™ Stiffness
Knee joint stiffness assessed with the validated Western Ontario and McMaster University questionnaire (WOMAC) using its visual analogue scale version (VAS). The WOMAC VA 3.1 Stiffness subscore (WOMAC B) ranges from 0 to 100 mm (averaging two VAS 0-100 mm) with higher scores indicating more stiffness.
Measured: 12-weeks
Change in WOMAC™ Physical function
Knee joint physical function assessed with the validated Western Ontario and McMaster University questionnaire (WOMAC) using its visual analogue scale version (VAS). The WOMAC VA 3.1 Physical function subscore (WOMAC C) ranges from 0 to 100 mm (averaging seventeen VAS 0-100 mm) with higher scores indicating more stiffness.
Measured: 12-weeks
Change in WOMAC™ Global Index
Knee joint global discomfort assessed through the sum of WOMAC A (pain), WOMAC B (stiffness) and WOMAC C (physical function) subscores. The WOMAC Global Index score ranges from 0 to 2400 mm (summing up twenty-four VAS 0-100 mm), with higher scores indicating higher disease burden.
Measured: 12-weeks
Pain intensity at rest
The pain intensity at rest is assessed using a VAS ranging from 0 to 100 mm, with higher scores indicating more pain.
Measured: 12-weeks
Pain intensity while walking
The pain intensity while walking is assessed using a VAS ranging from 0 to 100 mm, with higher scores indicating more pain.
Measured: 12-weeks
"Patient Global Assessment" (PGA)
The "Patient Global Assessment" (PGA) is the global assessment on joint discomfort and is assessed using a VAS ranging from 0 to 100 mm, with higher scores indicating more pain.
Measured: 12-weeks
OMERACT-OARSI criteria
Evaluation of the response to supplementation
Measured: 12-weeks
30s Chair Stand Physical Performance
Evaluation of the maximum number of chair stand repetitions possible in a 30 second period. Scoring results in a wide range of skill levels from 0, for those who cannot complete a single repetition and values greater than 20 for the well prepared individuals.
Measured: 12-weeks
40m Fast-paced Walked Physical Performance
A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) evaluating the ability to walk quickly over short distances. Time of one test trial is recorded and expressed as speed m/s by dividing distance (40m) by time (s).
Measured: 12-weeks
Stair Climb Physical Performance
Evaluates the time (in seconds) it takes to ascend and descend a flight of stairs. Timing begins on the signal to start and terminates when the participant returns with both feet to the ground level and the total time to ascend and descend steps for 1 test trial is recorded to nearest 100th of a second.
Measured: 12-weeks
Time up & Go Physical Performance
Evaluates the time (seconds) taken to rise from a chair, walk 3 m (9 ft 10 inches), turn, walk back to the chair, then sit down. Timing starts on the signal to start and terminates once the participant sits back down fully with their back resting on the back of the chair. Two trials are performed and the faster of the 2 trials is recorded to nearest 10th of a second.
Measured: 12-weeks
Quality of Life evaluation
Evaluation of Quality of life through SF-36 (RAND version), which is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher the score the less disability.
Measured: 12-weeks
Clinical Global Impression of Change (CGIC)
Physician assessment of joint swelling and range of motion (ROM) for knee extension/flexion, indicating the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Measured: 12-weeks
Assessment of use of rescue medicine
Evaluation of associated treatments needed to manage joint complains
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start24 Sep 2020
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artialis, Vizera d.o.o.
- Responsible party
- Sponsor
- Investigators
- Matija Tomšič, Prof., MD, Study chair, Univerzitetni klinični center Ljubljana, Klinični oddelek za revmatologijo, Ljubljana, SloveniaSamo K Fokter, MD, Principal investigator, Univerzitetni klinični center Maribor, Oddelek za ortopedijo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506411
- Sponsor's protocol ID
- 0120-118/2020/9
- Acronym
- T-MOTION
- Status last verified
- May 2023
- First submitted
- 29 Jul 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To revisit after investigation period
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Randomized Clinical Trial to Evaluate Efficacy of Turmipure Gold® to Improve Joint Function in Subjects With Distinct Kellgren-Lawrence Knee Radiographic Scores
- ClinicalTrials.gov ID
- NCT04506411
- Acronym / sponsor ID
- T-MOTION / 0120-118/2020/9
- Conditions
- Knee Discomfort, Joint Pain
- Keywords
- Mobility, Joint function, Turmeric, Curcuminoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Artialis, Vizera d.o.o.
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 10 Aug 2020 (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.
The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD® supplementation to reduce joint discomfort.
Detailed description
The aim of this clinical study is to determine whether oral administration of Turmipure GOLD® can contribute to the improvement of mobility and joint function in adult population with knee discomfort and with distinct Kellgren-Lawrence (K\&L) knee radiographic scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPG | Experimental | Dietary Supplement: Turmipure GOLD®59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 12 weeks |
| STE | Active comparator | Dietary Supplement: Turmeric rhizome PE 95% curcuminoids59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive standard turmeric extract 95% curcuminoids (STE) product during 12 weeks |
| Control | Placebo comparator | Dietary Supplement: Placebo59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (maltodextrin) product during 12 weeks |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consent to the study and to comply with study product
- Who have a BMI between 18 and 32 kg/m²
- Who has mild to moderate knee pain for at least 3 months before enrollment (VAS between 40 to 70 on 100mm scale after respecting a washout period depending on the half-life of the excluded medications)
- Who has radiographic evidence of Kellgren-Lawrence score 0, 1, 2 and 3 in the tibio-femoral compartment of the target knee
- Who is able to perform the physical performance-based tests and understands all questions from the WOMAC questionnaire
Key exclusion criteria (20 listed)
- Subjects with any clinically significant levels of the safety parameters at screening
- Pregnant or lactating females, or wishing to become pregnant during the study
- Subject with joint pain related to some predisposing conditions that have adversely altered the joint tissues often due to a specific cause
- Subject with Kellgren-Lawrence grade 4 in the tibio-femoral compartment of the target knee
- Who has clinically apparent tense effusion of the target knee or other joint
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 |
|---|---|---|
| Turmipure GOLD®TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed | Dietary supplement | TPG |
| Turmeric rhizome PE 95% curcuminoidsSTE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed | Dietary supplement | STE |
| PlaceboPlacebo: Maltodextrin - 4 capsules once daily- as prescribed | Dietary supplement | Control |
Primary outcome
Change in WOMAC™ Pain
Time frame: 12-weeks
Knee joint pain discomfort assessed with the validated Western Ontario and McMaster University questionnaire (WOMAC) using its visual analogue scale version (VAS). The WOMAC VA 3.1 Pain subscore (WOMAC A) ranges from 0 to 100 mm (averaging five VAS 0-100 mm) with higher scores indicating more pain.
14 secondary outcomes
Change in WOMAC™ Stiffness
Time frame: 12-weeks
Change in WOMAC™ Physical function
Time frame: 12-weeks
Change in WOMAC™ Global Index
Time frame: 12-weeks
Pain intensity at rest
Time frame: 12-weeks
Pain intensity while walking
Time frame: 12-weeks
"Patient Global Assessment" (PGA)
Time frame: 12-weeks
OMERACT-OARSI criteria
Time frame: 12-weeks
30s Chair Stand Physical Performance
Time frame: 12-weeks
40m Fast-paced Walked Physical Performance
Time frame: 12-weeks
Stair Climb Physical Performance
Time frame: 12-weeks
Time up & Go Physical Performance
Time frame: 12-weeks
Quality of Life evaluation
Time frame: 12-weeks
Clinical Global Impression of Change (CGIC)
Time frame: 12-weeks
Assessment of use of rescue medicine
Time frame: 12-weeks
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 3 May 2023.
- Individual participant dataSharing planned: Undecided. To revisit after investigation period
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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.
Matija Tomšič, Prof., MD study chair
Univerzitetni klinični center Ljubljana, Klinični oddelek za revmatologijo, Ljubljana, Slovenia
Samo K Fokter, MD principal investigator
Univerzitetni klinični center Maribor, Oddelek za ortopedijo
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turmipure GOLD® and Turmeric rhizome PE 95% curcuminoids in people with Knee Discomfort and Joint Pain, run by Givaudan France Naturals at 8 sites in 2 countries.
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 7 inclusion and 20 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Slovenia, Croatia. 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?
Change in WOMAC™ Pain (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.