The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD® supplementation to reduce joint discomfort.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
177
TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed
STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed
Placebo: Maltodextrin - 4 capsules once daily- as prescribed
Poliklinika Aviva
Zagreb, Croatia
Poliklinika Idassa
Zagreb, Croatia
Ortopedska bolnišnica Valdoltra
Ankaran, Slovenia
Splošna bolnišnica Jesenice, Oddelek za ortopedijo
Jesenice, Slovenia
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.
Time frame: 12-weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-weeks
Pain intensity while walking
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Bisturmed, d.o.o., Ortopedija in fizioterapija
Koper, Slovenia
Poliklinika Nobilis, d.o.o., enota LJ, Ortopedska ambulanta
Ljubljana, Slovenia
Medicinsko termalni center Fontana, d.o.o., Ortopedska ambulanta
Maribor, Slovenia
Univerzitetni klinični center Maribor, Oddelek za ortopedijo
Maribor, Slovenia
The pain intensity while walking is assessed using a VAS ranging from 0 to 100 mm, with higher scores indicating more pain.
Time frame: 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.
Time frame: 12-weeks
OMERACT-OARSI criteria
Evaluation of the response to supplementation
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-weeks
Assessment of use of rescue medicine
Evaluation of associated treatments needed to manage joint complains
Time frame: 12-weeks