The Effectiveness of a Herbal Supplement in Osteoarthritis.
Recruiting · NCT07324746 · Interventional (participants receive a specific treatment) · Lead sponsor: Middlesex University
View the official record on ClinicalTrials.gov →Interventions studied
Active treatmentPlacebo
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Middlesex Univeristy London - London, United Kingdom