This clinical study is a randomized, open-label, interventional trial designed to evaluate the safety and efficacy of a global CBD oral nanoformulation in patients with moderate to severe osteoarthritis (OA). Osteoarthritis is a degenerative joint disease characterized by joint pain, stiffness, and reduced mobility, often due to mechanical wear and tear. Current treatments such as NSAIDs and opioids offer symptomatic relief but are often associated with significant adverse effects. In this context, cannabidiol (CBD), known for its anti-inflammatory and analgesic properties, is being explored as a safer alternative. The study enrolls 60 adult participants aged 18–65 years who experience chronic joint pain with a baseline intensity of 6 or more on the Visual Analog Scale (VAS). Participants are randomly assigned into two groups: one receiving 5 ml of the CBD nanoformulation twice daily, and the other receiving a placebo, both for a duration of 90 days.

The primary objective is to assess the efficacy of the CBD nanoformulation in reducing OA symptoms and to compare its performance against a placebo. Symptom changes are measured using validated tools such as the VAS and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), focusing on pain, stiffness, and physical function from baseline to Day 90. Secondary objectives include evaluating the safety and tolerability of the formulation through adverse event reporting and laboratory assessments. Follow-up visits are scheduled on Day 30, Day 60, and Day 90, with clinical, biochemical, and compliance evaluations conducted at each stage.

This study adheres to Good Clinical Practice (GCP) guidelines and the Declaration of Helsinki, ensuring ethical conduct and participant safety. The findings of this trial aim to provide robust clinical evidence on the role of CBD nanoformulations as a non-opioid, plant-based therapeutic option in managing osteoarthritis, potentially improving patients’ quality of life with a favorable safety profile.