The Effectiveness of a Herbal Supplement in Osteoarthritis.

Middlesex University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis (OA)Osteoarthritis (OA) of the Hip Osteoarthritis (OA) of the Knee Osteoarthritis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Middlesex Univeristy London

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Patrycja Brodka Pedrp, MSc

CONTACT

020-8411-2721 p.x.brodkapedro@mdx.ac.uk

Lygeri Dimitriou, Dr

CONTACT

020-8411-4354 l.dimitriou@mdx.ac.uk

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

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)

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