An interventional study of Active treatment and Placebo in Osteoarthritis (OA), Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, sponsored by Middlesex University. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Middlesex University · Not applicable, Interventional, and Other
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:
Exclusion Criteria:
Dietary supplement containing standardised herbal extracts of Boswellia Serrata (525 mg), Curcuma Longa (150 mg), Vitis vinifera (75 mg)
Dietary Supplement: Active treatment
Dietary supplement placebo containing no standardised herbal extracts or other active ingredients.
Other: Placebo
A dietary supplement containing standardised herbal extracts of Boswellia serrata (525 mg), Curcuma longa (150 mg), Vitis vinifera (75 mg). Four times a day.
A 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from the start of the intervention to Week 4 of supplementation
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.
Time frame: Change from the start of the intervention to Week 4 of supplementation
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: The length of intervention: 4 weeks
Rescue medication
The use of rescue medication
Time frame: The length of intervention: 4 weeks
Satisfaction with remotely controlled study
Participants will be asked to complete a remote study satisfaction survey
Time frame: At the end of the study: 12 weeks
Plan to share: No
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Middlesex University