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Recruiting NCT07324746

The Effectiveness of a Herbal Supplement in Osteoarthritis.

No phase Interventional Osteoarthritis (OA) Osteoarthritis (OA) of the Hip Osteoarthritis (OA) of the Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active treatment, Placebo.
Who it may be relevant to
Registry conditions: Osteoarthritis (OA), Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee, Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of a Herbal Supplement Containing Boswellia Serrata, Curcuma Longa, and Vitis Vinifera in Patients With Osteoarthritis.

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

Interventions

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

Primary outcome measures

  • 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]
  • Change in Numeric Rating Scale (NRS) score [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 [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 [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 [Time frame: Change from the start of the intervention to Week 4 of supplementation]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • Middlesex Univeristy London — London

Identifiers

NCT: NCT07324746 · 30400

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗