Osteoarthritis (OA)NCT07324746
The Effectiveness of a Herbal Supplement in Osteoarthritis.
A study testing Active treatment in people with Osteoarthritis (OA) and Osteoarthritis (OA) of the Hip, run by Middlesex University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA), Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee
- What is being tested?
- Active treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Middlesex Univeristy London
London, NW4 4BT
Patrycja Brodka Pedro, MSc, p.x.brodkapedro@mdx.ac.uk
Lygeri Dimitriou, Dr, l.dimitriou@mdx.ac.uk
About this study
Official title: Effectiveness of a Herbal Supplement Containing Boswellia Serrata, Curcuma Longa, and Vitis Vinifera in Patients With 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
- Conditions
- Osteoarthritis (OA), Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee, Osteoarthritis
- Being tested
- Active treatment, Placebo
- Keywords
- Boswellia serrata, Curcuma longa, Curcumin, Turmeric, Osteoarthritis, Grape extract, Knee osteoarthritis, Hip osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active treatmentDietary 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.
PlaceboOther
A placebo containing no standardised herbal extracts or other active ingredients. Four times a day.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Dietary supplement containing standardised herbal extracts of Boswellia Serrata (525 mg), Curcuma Longa (150 mg), Vitis vinifera (75 mg) Receives: Dietary Supplement: Active treatment |
| Placebo | Placebo comparator | Dietary supplement placebo containing no standardised herbal extracts or other active ingredients. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from the start of the intervention to Week 4 of supplementation
Secondary outcomes (15)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: The length of intervention: 4 weeks
Rescue medication
The use of rescue medication
Measured: The length of intervention: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start5 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomised, double-blind, crossover study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middlesex University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrycja Brodka Pedro, Middlesex University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324746
- Sponsor's protocol ID
- 30400
- Status last verified
- Jun 2025
- First submitted
- 24 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Herbal Supplement Containing Boswellia Serrata, Curcuma Longa, and Vitis Vinifera in Patients With Osteoarthritis.
- ClinicalTrials.gov ID
- NCT07324746
- Acronym / sponsor ID
- 30400
- Conditions
- Osteoarthritis (OA), Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee, Osteoarthritis
- Keywords
- Boswellia serrata, Curcuma longa, Curcumin, Turmeric, Osteoarthritis, Grape extract, Knee osteoarthritis, Hip osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Middlesex UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised, double-blind, crossover study.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Dietary Supplement: Active treatmentDietary supplement containing standardised herbal extracts of Boswellia Serrata (525 mg), Curcuma Longa (150 mg), Vitis vinifera (75 mg) |
| Placebo | Placebo comparator | Other: PlaceboDietary supplement placebo containing no standardised herbal extracts or other active ingredients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active treatmentA dietary supplement containing standardised herbal extracts of Boswellia serrata (525 mg), Curcuma longa (150 mg), Vitis vinifera (75 mg). Four times a day. | Dietary supplement | Active Treatment |
| PlaceboA placebo containing no standardised herbal extracts or other active ingredients. Four times a day. | Other | Placebo |
Primary outcome
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).
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.
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.
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.
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.
15 secondary outcomes
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score.
Time frame: Change from baseline to the end of Week 1 of supplementation
Change in Numeric Rating Scale (NRS) score
Time frame: Change from baseline to the end of Week 1 of supplementation
Change in Intermittent and Constant Osteoarthritis Pain knee/hip (ICOAP) score
Time frame: Change from baseline to the end of Week 1 of supplementation
Change in Lequesne Functional Index (LFI) score
Time frame: Change from baseline to the end of Week 1 of supplementation
Change in Lequesne Functional Index (LFI) score
Time frame: Change from the start of the intervention to Week 4 of supplementation
Evaluation of Minimal Clinically Important Difference for measured scores
Time frame: Change from the start of the intervention to Week 4 of supplementation
Change in 30-Second Chair Stand Test
Time frame: Change from baseline to the end of Week 1 of supplementation
Change in 30-Second Chair Stand Test
Time frame: Change from the start of the intervention to Week 4 of supplementation
Change in Stair Climb Test
Time frame: Change from baseline to the end of Week 1 of supplementation
Change in Stair Climb Test
Time frame: Change from the start of the intervention to Week 4 of supplementation
Change in 40-metre Fast-Paced Walk Test
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)
Time frame: Change from the start of the intervention to Week 4 of supplementation
Global Physical Activity Questionnaire
Time frame: Change from the start of the intervention to Week 4 of supplementation
Adverse events
Time frame: The length of intervention: 4 weeks
Rescue medication
Time frame: The length of intervention: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active treatment in people with Osteoarthritis (OA) and Osteoarthritis (OA) of the Hip, run by Middlesex University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrycja Brodka Pedrp, MSc (020-8411-2721, p.x.brodkapedro@mdx.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.