The Effectiveness of a Herbal Supplement in Osteoarthritis.

Middlesex University

Status: Enrolling

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

Treatments: Dietary Supplement: Active treatment; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07324746

30400

Details and patient eligibility

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Active Treatment

Experimental group

Description:

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

Treatment:

Dietary Supplement: Active treatment

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo