Comparison Between Mobithron® and Crystalline Glucosamine Sulphate in Patients With Knee Osteoarthritis

Knee osteoarthritis is one of the most common degenerative musculoskeletal disorders and is a major cause of chronic pain, reduced physical function, and impaired quality of life among older adults. Conservative treatment remains the cornerstone of management for patients with early to moderate disease and includes exercise therapy, physiotherapy, weight management, analgesics, and oral nutraceutical supplements. Although crystalline glucosamine sulphate is widely prescribed for symptomatic knee osteoarthritis, published evidence regarding its clinical effectiveness remains inconsistent.

Mobithron® is a multi-component oral formulation containing oral hyaluronic acid matrix (Mobilee®), undenatured type II collagen, and Boswellia serrata extract (ApresFlex™). These ingredients have individually demonstrated potential benefits in osteoarthritis through complementary mechanisms, including enhancement of joint lubrication, stimulation of endogenous hyaluronic acid synthesis, immunomodulatory effects that may support cartilage integrity, and inhibition of inflammatory pathways. However, evidence evaluating the combined formulation in comparison with established oral supplements is limited.

This study was designed to compare the clinical effectiveness and safety of Mobithron® with crystalline glucosamine sulphate in patients with primary knee osteoarthritis.

This was a single-centre, prospective, randomized, open-label, parallel-group clinical study conducted at the Sultan Ahmad Shah Medical Centre, International Islamic University Malaysia. Eligible patients aged 50 to 75 years with Kellgren-Lawrence grade II-IV primary knee osteoarthritis were randomized in a 1:1 ratio to receive either Mobithron® once daily or crystalline glucosamine sulphate 1500 mg once daily for three months. Medication allocation was performed by an independent pharmacist using a predetermined allocation schedule, while clinicians and outcome assessors remained blinded to treatment allocation. All participants underwent the same standardized rehabilitation programme consisting of supervised physiotherapy and prescribed home-based exercises throughout the study period.

Clinical assessments were performed at baseline, Week 2, Week 4, and Month 3. The primary outcome was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score from baseline. Secondary outcomes included changes in WOMAC pain, stiffness, and physical function subscales, Visual Analogue Scale (VAS) pain scores at rest and during movement, treatment compliance, analgesic consumption, and safety, including adverse event monitoring throughout the study.

The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles. Ethical approval was obtained from the IIUM Research Ethics Committee (IREC), Sultan Ahmad Shah Medical Centre @ International Islamic University Malaysia (Approval ID: IREC 2024-229; Reference No.: IIUM/504/14/11/2/IREC 2024-229), and written informed consent was obtained from all participants before enrolment.

Inclusion criteria

• Adults aged 50 to 75 years.
• Diagnosis of primary knee osteoarthritis.
• Radiographic Kellgren-Lawrence grade II, III, or IV knee osteoarthritis.
• No previous surgical intervention to the affected knee.
• At least 6 months since the last intra-articular injection to the affected knee.
• Able and willing to comply with the rehabilitation programme and follow-up -schedule.
• Provided written informed consent.

Exclusion criteria

• History of infection involving the affected knee.
• Secondary osteoarthritis (e.g., inflammatory arthritis).
• Unable to comply with the rehabilitation programme or follow-up schedule.
• Declined or unable to provide informed consent.
• Women of child-bearing potential.
• History of severe allergic reactions, including anaphylaxis.
• Severe knee pain at screening (VAS ≥7).
• Minimal or no knee pain at screening (VAS ≤3).