RecruitingNot Applicable

The Effectiveness of a Herbal Supplement in Osteoarthritis.

United Kingdom30 participantsStarted 2025-12-05

Plain-language 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. 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Change from the start of the intervention to Week 4 of supplementation

Change in Numeric Rating Scale (NRS) score

Timeframe: Change from the start of the intervention to Week 4 of supplementation

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

Timeframe: Change from the start of the intervention to Week 4 of supplementation

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

Timeframe: 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

Timeframe: Change from the start of the intervention to Week 4 of supplementation

Trial details

NCT IDNCT07324746

SponsorMiddlesex University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Patrycja Brodka Pedrp, MSc

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

View on ClinicalTrials.gov More Osteoarthritis (OA) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Change from the start of the intervention to Week 4 of supplementation

Change in Numeric Rating Scale (NRS) score

Timeframe: Change from the start of the intervention to Week 4 of supplementation

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

Timeframe: Change from the start of the intervention to Week 4 of supplementation

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

Timeframe: 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

Timeframe: Change from the start of the intervention to Week 4 of supplementation