The Effectiveness of a Herbal Supplement in Osteoarthritis.

NCT07324746 | Recruiting

• 1 other identifier: 30400
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

Boswellia serrata; Curcuma longa; Curcumin; Turmeric; Osteoarthritis; Grape extract; Knee osteoarthritis; Hip osteoarthritis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (15)

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

  Change from baseline to the end of Week 1 of supplementation

• Change in Numeric Rating Scale (NRS) score

  Change from baseline to the end of Week 1 of supplementation

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

  Change from baseline to the end of Week 1 of supplementation

• Change in Lequesne Functional Index (LFI) score

  Change from baseline to the end of Week 1 of supplementation

• Change in Lequesne Functional Index (LFI) score

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

Other Outcomes (1)

• Satisfaction with remotely controlled study

  At the end of the study: 12 weeks

Study Arms (2)

Active Treatment

EXPERIMENTAL

Dietary supplement containing standardised herbal extracts of Boswellia Serrata (525 mg), Curcuma Longa (150 mg), Vitis vinifera (75 mg)

Dietary Supplement: Active treatment

Placebo

PLACEBO COMPARATOR

Dietary supplement placebo containing no standardised herbal extracts or other active ingredients.

Other: Placebo

Interventions

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.

Active Treatment

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Middlesex University: lead

Study Sites (1)

Middlesex Univeristy London

London, NW4 4BT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student in Biomedicine, Bioscience Laboratory Technician

Model Details: A randomised, double-blind, crossover study.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)