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NCT Number: NCT07324746

The Effectiveness of a Herbal Supplement in Osteoarthritis.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Middlesex Univeristy London

London, NW4 4BT, United Kingdom

Location status: Recruiting

Location contact

Frank Hills, Professor

SUB_INVESTIGATOR

Lygeri Dimitriou, Dr

CONTACT

[email protected]

Lygeri Dimitriou, Dr

SUB_INVESTIGATOR

Patrycja Brodka Pedro, MSc

CONTACT

[email protected]

Patrycja Brodka Pedro, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ambulant patient

Exclusion criteria

  • 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
  • History of the viscous or corticosteroids injections into affected joints or oral corticosteroids within last 12 months
  • Allergy to one of the intervention's ingredients or NSAIDs
  • Peptic ulceration and upper gastrointestinal haemorrhage
  • High alcohol intake, inability to abstain from alcohol, substance abuse, history of addiction
  • Tumor, cancer
  • Abnormal renal or/and hepatic functions or altered blood chemistry
  • Use of concomitant medication able to interfere with the interventions

Treatment and study plan

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.

Placebo

Other

A placebo containing no standardised herbal extracts or other active ingredients. Four times a day.

Primary outcomes

  1. Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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).

  2. Change in Numeric Rating Scale (NRS) score

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

  3. Change in Intermittent and Constant Osteoarthritis Pain knee/hip (ICOAP) score

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

  4. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) score

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

  5. Change in urinary C-terminal telopeptide of type II collagen (uCTX-II) levels

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

Secondary outcomes

  1. Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score.

    Time frame: Change from baseline to the end of Week 1 of supplementation

    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).

  2. Change in Numeric Rating Scale (NRS) score

    Time frame: Change from baseline to the end of Week 1 of supplementation

    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.

  3. Change in Intermittent and Constant Osteoarthritis Pain knee/hip (ICOAP) score

    Time frame: Change from baseline to the end of Week 1 of supplementation

    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.

  4. Change in Lequesne Functional Index (LFI) score

    Time frame: Change from baseline to the end of Week 1 of supplementation

    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.

  5. Change in Lequesne Functional Index (LFI) score

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

  6. Evaluation of Minimal Clinically Important Difference for measured scores

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    Minimal Clinically Important Difference assessed by Patient Global Impression of Change.

    PGIC is a specialised patient-reported outcome tool.

  7. Change in 30-Second Chair Stand Test

    Time frame: Change from baseline to the end of Week 1 of supplementation

    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.

  8. Change in 30-Second Chair Stand Test

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

  9. Change in Stair Climb Test

    Time frame: Change from baseline to the end of Week 1 of supplementation

    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.

  10. Change in Stair Climb Test

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

  11. Change in 40-metre Fast-Paced Walk Test

    Time frame: Change from baseline to the end of Week 1 of supplementation

    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.

  12. Change in the 40-metre Fast-Paced Walk Test (4 × 10 m)

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    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.

  13. Global Physical Activity Questionnaire

    Time frame: Change from the start of the intervention to Week 4 of supplementation

    The GPAQ will be used to monitor physical activity patterns in participants, and detect possible changes.

  14. Adverse events

    Time frame: The length of intervention: 4 weeks

    Collection of adverse events to assess the safety and tolerability of the supplement

  15. Rescue medication

    Time frame: The length of intervention: 4 weeks

    The use of rescue medication

Other outcomes

  1. Satisfaction with remotely controlled study

    Time frame: At the end of the study: 12 weeks

    Participants will be asked to complete a remote study satisfaction survey

Study contacts

Contact information is provided by the study sponsor or research team.

Lygeri Dimitriou, Dr

CONTACT

[email protected]

020-8411-4354

Patrycja Brodka Pedrp, MSc

CONTACT

[email protected]

020-8411-2721

Sponsors and collaborators

Lead sponsor

Middlesex University

Other

Registry information

Official study title

Effectiveness of a Herbal Supplement Containing Boswellia Serrata, Curcuma Longa, and Vitis Vinifera in Patients With Osteoarthritis.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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