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| Name | Class |
|---|---|
| Artialis | INDUSTRY |
| Vizera d.o.o. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPG | Experimental | 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 | 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turmipure GOLD® | Dietary Supplement | TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matija Tomšič, Prof., MD | Univerzitetni klinični center Ljubljana, Klinični oddelek za revmatologijo, Ljubljana, Slovenia | Study Chair |
| Samo K Fokter, MD | Univerzitetni klinični center Maribor, Oddelek za ortopedijo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliklinika Aviva | Zagreb | Croatia | ||||
| Poliklinika Idassa |
To revisit after investigation period
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| ID | Term |
|---|---|
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Turmeric rhizome PE 95% curcuminoids | Dietary Supplement | STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed |
|
| Placebo | Dietary Supplement | Placebo: Maltodextrin - 4 capsules once daily- as prescribed |
|
| 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. |
| 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. | 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. | 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. | 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. | 12-weeks |
| OMERACT-OARSI criteria | Evaluation of the response to supplementation | 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. | 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). | 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. | 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. | 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. | 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. | 12-weeks |
| Assessment of use of rescue medicine | Evaluation of associated treatments needed to manage joint complains | 12-weeks |
| Zagreb |
| Croatia |
| Ortopedska bolnišnica Valdoltra | Ankaran | Slovenia |
| Splošna bolnišnica Jesenice, Oddelek za ortopedijo | Jesenice | Slovenia |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |