An interventional study of Mobithron® and Crystalline Glucosamine Sulphate in Knee Osteoarthritis, sponsored by BREGO Life Sciences. Completed at 1 site in Malaysia. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by BREGO Life Sciences · Not applicable, Interventional, and Treatment
Knee osteoarthritis is a common degenerative joint disorder that causes pain, functional limitation, and reduced quality of life. This prospective, randomized, open-label, parallel-group study was conducted to compare the clinical effectiveness and safety of Mobithron®, a multi-component oral formulation containing hyaluronic acid matrix, undenatured type II collagen, and Boswellia serrata extract, with crystalline glucosamine sulphate in patients with primary knee osteoarthritis. Participants received either Mobithron® or crystalline glucosamine sulphate for three months in addition to a standardized rehabilitation programme. Clinical outcomes were assessed 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. Secondary outcomes included pain severity measured using the Visual Analogue Scale (VAS) and safety assessment through adverse event monitoring.
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →This is the only study on the registry with BREGO Life Sciences as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received Mobithron® orally once daily for 3 months in addition to a standardized rehabilitation programme comprising supervised physiotherapy and prescribed home-based exercises.
Dietary Supplement: Mobithron®
Participants received crystalline glucosamine sulphate 1500 mg orally once daily for 3 months in addition to the same standardized rehabilitation programme comprising supervised physiotherapy and prescribed home-based exercises.
Dietary Supplement: Crystalline Glucosamine Sulphate
Mobithron® is an oral nutraceutical formulation containing hyaluronic acid matrix (Mobilee® 80 mg, providing 45 mg hyaluronic acid), undenatured type II collagen (10 mg), and Boswellia serrata extract (ApresFlex™ 100 mg). Participants received one oral dose daily for 3 months in addition to a standardized rehabilitation programme.
Crystalline glucosamine sulphate 1500 mg was administered orally once daily for 3 months in addition to the same standardized rehabilitation programme.
Change in Western Ontario and McMaster Universities Osteoarthritis Index Total Score
Change from baseline in functional status measured using the Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Likert questionnaire. The instrument contains 24 items across pain, stiffness and physical-function domains. Each item is scored from 0 to 4, producing a total score ranging from 0 to 96. Higher scores indicate greater pain, stiffness and functional impairment; therefore, a reduction from baseline indicates improvement.
Time frame: Baseline, Week 2, Week 4, and Month 3
Change in Visual Analogue Scale Pain Score
Change from baseline in pain severity measured using the Visual Analogue Scale. Pain is rated from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity; therefore, a reduction from baseline indicates improvement. Pain was assessed separately at rest and during movement.
Time frame: Baseline, Week 2, Week 4, and Month 3
Plan to share: No — The individual participant data generated and analysed during this study are not publicly available due to confidentiality and institutional restrictions.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.