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:
* take the supplement and placebo for 4 weeks each, one at a time; * complete validated questionnaires (6 times online) * perform three performance-based physical tests (6 times online) * provide a urine sample
Aged ≥ 18
Diagnosis of osteoarthritis in knee or hip
Numerical Rating Scale (NRS) ≥ 4 during the most painful movement in the last 24 hours
Lequesne's Functional Index (LFI) score ≥ 7
Pregnant and breastfeeding
Autoimmune disease such as rheumatoid arthritis, gout, lupus
Joint trauma, joint injury, joint infection, meniscus tear, complete loss of articular cartilage
Expectation of surgery
Crossover
Active treatment
Dietary supplementA dietary supplement containing standardised herbal extracts of Boswellia serrata (525 mg), Curcuma longa (150 mg), Vitis vinifera (75 mg). Four times a day.
Placebo
Other interventionA placebo containing no standardised herbal extracts or other active ingredients. Four times a day.
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 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 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 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 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 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 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 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.
Satisfaction with remotely controlled study
Participants will be asked to complete a remote study satisfaction survey
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