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This study aims to evaluate the effectiveness and safety of a combined herbal supplement containing Boswellia serrata, Curcuma longa, and Vitis vinifera in adults with clinically diagnosed knee or hip osteoarthritis.
The primary objective is to determine whether the supplement improves osteoarthritis-related symptoms.
The supplement will be compared with a placebo.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Dietary supplement containing standardised herbal extracts of Boswellia Serrata (525 mg), Curcuma Longa (150 mg), Vitis vinifera (75 mg) |
|
| Placebo | Placebo Comparator | Dietary supplement placebo containing no standardised herbal extracts or other active ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active treatment | Dietary Supplement | A dietary supplement containing standardised herbal extracts of Boswellia serrata (525 mg), Curcuma longa (150 mg), Vitis vinifera (75 mg). Four times a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score | Western Ontario and McMaster Universities Arthritis Index, a validated, specialised instrument used to assess pain, stiffness, and physical function in people with osteoarthritis. Scores range from 0 to 96 (Likert version), with higher scores indicating worse pain (0-20), stiffness (0-8), and physical function (0-68). | Change from the start of the intervention to Week 4 of supplementation |
| Change in Numeric Rating Scale (NRS) score | Numeric Rating Scale. A specialised pain assessment tool, where patients rate their pain intensity on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate worse outcomes. | Change from the start of the intervention to Week 4 of supplementation |
| Change in Intermittent and Constant Osteoarthritis Pain knee/hip (ICOAP) score | ICOAP. A Measure of Intermittent and Constant Osteoarthritis Pain knee/hip To assess two distinct types of pain experienced by people with osteoarthritis-intermittent pain (comes and goes, 0 - 24) and constant pain (persistent, ongoing pain, 0 - 20). Scores range from 0 to 44, with higher scores indicating more severe osteoarthritis related pain. | Change from the start of the intervention to Week 4 of supplementation |
| Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) score | EuroQol 5-Dimension 5-Level questionnaire. A generic, widely used tool to measure health-related quality of life. It measures five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. A score of 1 indicates no problems, while 5 indicates extreme problems in the respective dimension. In addition, the EQ Visual Analogue Scale (EQ-VAS) records the respondent's self-rated health on a vertical scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | Change from the start of the intervention to Week 4 of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score. | Western Ontario and McMaster Universities Arthritis Index, a validated, specialised instrument used to assess pain, stiffness, and physical function in people with osteoarthritis. Scores range from 0 to 96 (Likert version), with higher scores indicating worse pain (0-20), stiffness (0-8), and physical function (0-68). |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with remotely controlled study | Participants will be asked to complete a remote study satisfaction survey | At the end of the study: 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrycja Brodka Pedrp, MSc | Contact | 020-8411-2721 | p.x.brodkapedro@mdx.ac.uk | |
| Lygeri Dimitriou, Dr | Contact | 020-8411-4354 | l.dimitriou@mdx.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Middlesex Univeristy London | Recruiting | London | NW4 4BT | United Kingdom |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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A randomised, double-blind, crossover study.
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| Placebo | Other | A placebo containing no standardised herbal extracts or other active ingredients. Four times a day. |
|
| Change in urinary C-terminal telopeptide of type II collagen (uCTX-II) levels | uCTX-II (urinary C-terminal telopeptide of type II collagen) is a biochemical marker measured in urine that reflects type II collagen degradation, which occurs primarily in articular cartilage. | Change from the start of the intervention to Week 4 of supplementation |
| Change from baseline to the end of Week 1 of supplementation |
| Change in Numeric Rating Scale (NRS) score | Numeric Rating Scale. A specialised pain assessment tool, where patients rate their pain intensity on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate worse outcomes. | Change from baseline to the end of Week 1 of supplementation |
| Change in Intermittent and Constant Osteoarthritis Pain knee/hip (ICOAP) score | ICOAP. A Measure of Intermittent and Constant Osteoarthritis Pain knee/hip To assess two distinct types of pain experienced by people with osteoarthritis-intermittent pain (comes and goes, 0 - 24) and constant pain (persistent, ongoing pain, 0 - 20). Scores range from 0 to 44, with higher scores indicating more severe osteoarthritis related pain. | Change from baseline to the end of Week 1 of supplementation |
| Change in Lequesne Functional Index (LFI) score | Lequesne Functional Index. A specialised questionnaire used to evaluate the severity of osteoarthritis and its impact on daily function, particularly for the hip and knee. Scores range from 0 to 24, with higher scores indicating greater severity and worse functional impairment. | Change from baseline to the end of Week 1 of supplementation |
| Change in Lequesne Functional Index (LFI) score | Lequesne Functional Index. A specialised questionnaire used to evaluate the severity of osteoarthritis and its impact on daily function, particularly for the hip and knee. Scores range from 0 to 24, with higher scores indicating greater severity and worse functional impairment. | Change from the start of the intervention to Week 4 of supplementation |
| Evaluation of Minimal Clinically Important Difference for measured scores | Minimal Clinically Important Difference assessed by Patient Global Impression of Change. PGIC is a specialised patient-reported outcome tool. | Change from the start of the intervention to Week 4 of supplementation |
| Change in 30-Second Chair Stand Test | 30-Second Chair Stand Test is a functional assessment that measures lower-body strength and endurance by recording the number of times an individual can rise to a full standing position from a seated position in 30 seconds, without using their arms. | Change from baseline to the end of Week 1 of supplementation |
| Change in 30-Second Chair Stand Test | 30-Second Chair Stand Test is a functional assessment that measures lower-body strength and endurance by recording the number of times an individual can rise to a full standing position from a seated position in 30 seconds, without using their arms. | Change from the start of the intervention to Week 4 of supplementation |
| Change in Stair Climb Test | Stair Climb Test is a functional performance assessment that measures lower-limb strength, power, and mobility by timing how quickly an individual ascends and descends a set of stairs. | Change from baseline to the end of Week 1 of supplementation |
| Change in Stair Climb Test | Stair Climb Test is a functional performance assessment that measures lower-limb strength, power, and mobility by timing how quickly an individual ascends and descends a set of stairs. | Change from the start of the intervention to Week 4 of supplementation |
| Change in 40-metre Fast-Paced Walk Test | The 40-metre Fast-Paced Walk Test (4 × 10 m) is a functional mobility assessment that measures walking speed and dynamic balance by timing how quickly an individual completes four 10-metre walks at a fast but safe pace. | Change from baseline to the end of Week 1 of supplementation |
| Change in the 40-metre Fast-Paced Walk Test (4 × 10 m) | The 40-metre Fast-Paced Walk Test (4 × 10 m) is a functional mobility assessment that measures walking speed and dynamic balance by timing how quickly an individual completes four 10-metre walks at a fast but safe pace. | Change from the start of the intervention to Week 4 of supplementation |
| Global Physical Activity Questionnaire | The GPAQ will be used to monitor physical activity patterns in participants, and detect possible changes. | Change from the start of the intervention to Week 4 of supplementation |
| Adverse events | Collection of adverse events to assess the safety and tolerability of the supplement | The length of intervention: 4 weeks |
| Rescue medication | The use of rescue medication | The length of intervention: 4 weeks |