- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506411
Turmeric Efficacy for Mobility and Joint Function (T-MOTION)
May 2, 2023 updated by: Naturex SA
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
177
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zagreb, Croatia
- Poliklinika Aviva
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Zagreb, Croatia
- Poliklinika Idassa
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Ankaran, Slovenia
- Ortopedska bolnišnica Valdoltra
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Jesenice, Slovenia
- Splošna bolnišnica Jesenice, Oddelek za ortopedijo
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Koper, Slovenia
- Bisturmed, d.o.o., Ortopedija in fizioterapija
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Ljubljana, Slovenia
- Poliklinika Nobilis, d.o.o., enota LJ, Ortopedska ambulanta
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Maribor, Slovenia
- Medicinsko termalni center Fontana, d.o.o., Ortopedska ambulanta
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Maribor, Slovenia
- Univerzitetni klinični center Maribor, Oddelek za ortopedijo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TPG
59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 12 weeks
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TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed
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Active Comparator: STE
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
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STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed
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Placebo Comparator: Control
59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (maltodextrin) product during 12 weeks
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Placebo: Maltodextrin - 4 capsules once daily- as prescribed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in WOMAC™ Pain
Time Frame: 12-weeks
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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.
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12-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in WOMAC™ Stiffness
Time Frame: 12-weeks
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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.
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12-weeks
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Change in WOMAC™ Physical function
Time Frame: 12-weeks
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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.
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12-weeks
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Change in WOMAC™ Global Index
Time Frame: 12-weeks
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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.
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12-weeks
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Pain intensity at rest
Time Frame: 12-weeks
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The pain intensity at rest is assessed using a VAS ranging from 0 to 100 mm, with higher scores indicating more pain.
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12-weeks
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Pain intensity while walking
Time Frame: 12-weeks
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The pain intensity while walking is assessed using a VAS ranging from 0 to 100 mm, with higher scores indicating more pain.
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12-weeks
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"Patient Global Assessment" (PGA)
Time Frame: 12-weeks
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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.
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12-weeks
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OMERACT-OARSI criteria
Time Frame: 12-weeks
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Evaluation of the response to supplementation
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12-weeks
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30s Chair Stand Physical Performance
Time Frame: 12-weeks
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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.
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12-weeks
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40m Fast-paced Walked Physical Performance
Time Frame: 12-weeks
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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).
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12-weeks
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Stair Climb Physical Performance
Time Frame: 12-weeks
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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.
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12-weeks
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Time up & Go Physical Performance
Time Frame: 12-weeks
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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.
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12-weeks
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Quality of Life evaluation
Time Frame: 12-weeks
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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.
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12-weeks
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Clinical Global Impression of Change (CGIC)
Time Frame: 12-weeks
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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.
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12-weeks
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Assessment of use of rescue medicine
Time Frame: 12-weeks
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Evaluation of associated treatments needed to manage joint complains
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12-weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Matija Tomšič, Prof., MD, Univerzitetni klinični center Ljubljana, Klinični oddelek za revmatologijo, Ljubljana, Slovenia
- Principal Investigator: Samo K Fokter, MD, Univerzitetni klinični center Maribor, Oddelek za ortopedijo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2020
Primary Completion (Actual)
March 3, 2023
Study Completion (Actual)
March 3, 2023
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
August 7, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0120-118/2020/9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
To revisit after investigation period
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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