The Effectiveness of a Herbal Supplement in Osteoarthritis.

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

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Osteoarthritis (OA); Osteoarthritis (OA) of the Knee; Osteoarthritis (OA) of the Hip
• Intervention / Treatment: Dietary supplement: Active treatment; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrycja Brodka Pedrp, MSc; Phone Number: 020-8411-2721; Email: p.x.brodkapedro@mdx.ac.uk
• Study Contact Backup: Name: Lygeri Dimitriou, Dr; Phone Number: 020-8411-4354; Email: l.dimitriou@mdx.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, NW4 4BT
    • Recruiting
    • Middlesex Univeristy London
    • Contact: Patrycja Brodka Pedro, MSc; Email: p.x.brodkapedro@mdx.ac.uk
    • Contact: Lygeri Dimitriou, Dr; Email: l.dimitriou@mdx.ac.uk
    • Principal Investigator: Patrycja Brodka Pedro, MSc
    • Sub-Investigator: Lygeri Dimitriou, Dr
    • Sub-Investigator: Frank Hills, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment; Dietary supplement containing standardised herbal extracts of Boswellia Serrata (525 mg), Curcuma Longa (150 mg), Vitis vinifera (75 mg)	Dietary supplement: Active treatment; 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 Comparator: Placebo; Dietary supplement placebo containing no standardised herbal extracts or other active ingredients.	Other: Placebo; A placebo containing no standardised herbal extracts or other active ingredients. Four times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Middlesex University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee osteoarthritis; Turmeric; Curcumin; Grape extract; Hip osteoarthritis; Boswellia serrata; Curcuma longa
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: 30400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No